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Report Narrative

Description of Event or Problem

This was a newborn with a large diaphragmatic hernia, who was placed on extracorporal membrane oxygenation - ecmo-. Immediately after ecmo was begun, she developed diffuse petechial lesions which progressed to purpura and hypertension, then dic. She continued to deteriorate and died from hemorrhage secondary to dic. Heparin coated carmeda tubing was used during ecmo and this report is being filed retrospectively after the heparin recall and the 04/08/08 fda letter to manufacturers asking them to consider withdrawal of heparin coated devices. Diagnosis or reason for use: oxygenation.

Narrative Key: 788225

General Information About The Event

Date of event: 2008-01-20

Date initial reporter provided information: 2008-04-14

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Voluntary report

Is reporter a health professional: Y

Initial reporter occupation: Risk Manager

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Carmeda circuit - heparin coated, Carmeda circuit - heparin coated

Device Event Key: 970812

FDA Product Code Classification: DTZ

Model Number: *

Catalog Number: *

Lot Number: 8664127

Expiration Date of Device:

Age of Device:

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 8094441

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8303917

Description of Event or Problem

The customer contacted abbott regarding hemoglobin syringe "fail to home" error messages generated five times in one day from the cell-dyn sapphire hematology analyzer. The customer was able to clear the error message with temporary resolution. The abbott customer technical advocate recommended the customer clean the syringe and if the syringe plunger was difficult to move, replace the syringe. The issue was resolved when the customer replaced the syringe. The customer reported there was no impact to pt management.

Narrative Key: 788224

General Information About The Event

Date of event: 2007-12-16

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Replace"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8321587

Description of Event or Problem

The customer contacted abbott regarding hemoglobin syringe "fail to home" error messages generated from the cell-dyn sapphire hematology analyzer. The customer states the hemoglobin syringe locked up and the plunger would not move when the syringe was removed for weekly cleaning. The customer replaced the syringe and no further error messages were generated. The customer requested replacement syringes and reported there was no further issues. The customer reported there was no impact to pt management.

Narrative Key: 15604222

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 15887480

General Information About The Event

Date of event: 2007-12-14

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Recall"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.

Narrative Key: 7934126

Description of Event or Problem

Form 3500 must be submitted if a secondary malignant finding occurred. In 2008, mammogram and core biopsy revealed microcalcifications of the left breast - original diagnosis on right side - and a stereotactic core showed dcis.

Narrative Key: 1255386

Additional Manufacturer Narrative

(b)(4). Cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(6) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(6) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(6) 2009.

Narrative Key: 8322422

Description of Event or Problem

The customer contacted abbott regarding intermittent hemoglobin syringe "fail to home" error messages generated from the cell-dyn sapphire hematology analyzer. The customer states the syringe was cleaned and reseated, but error recurred within an hour of syringe cleaning. The customer was instructed to power down the analyzer, but following re-boot of the analyzer, the analyzer primed, and the syringe error recurred during quality control sampling. The abbott customer technical advocate dispatched service to the customer facility. Prior to service arriving at the customer facility, the customer installed a new syringe and the issue was resolved. The customer reported there was no impact to pt management.

Narrative Key: 788210

General Information About The Event

Date of event: 2007-12-10

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Relabeling"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8322005

Description of Event or Problem

The customer contacted abbott regarding frequent hemoglobin syringe "fail to home" error messages occuring throughout the day from the cell-dyn sapphire hematology analyzer. The customer had not performed any troubleshooting procedures and the customer was instructed to clean and reseat the syringe. The issue persisted and the customer requested service for the analyzer. The abbott field service rep replaced the syringe, assayed samples without recurrence of error messages and verified the assay controls were within specs. The customer reported there was no impact to pt mgmt.

Narrative Key: 788211

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 8094442

General Information About The Event

Date of event: 2007-12-08

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: Y

Initial reporter occupation: Medical Technologist

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Recall"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Description of Event or Problem

The customer contacted abbot regarding hemaglobin syringe "fail to home" error messages generated from the cell-dyn sapphire hematology analyzer. When the customer removed the syringe to clean it, the syringe plunger was stuck very tightly in the syringe barrel requiring enough force to remove it, that the plunger came all the way out. The customer replaced the syringe which resolved the issue. The customer reported there was no impact to pt management.

Narrative Key: 788226

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8322004

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 7934127

General Information About The Event

Date of event: 2007-12-05

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Replace"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Description of Event or Problem

This pt was the first case of the day and the anesthesia machine had been checked according to the standard checkout procedure recommended by the american society of anesthesiologists. The peak inspiratory pressures read by the machine (ohmeda) spirometer on the ventilator and the extra adaptable spirometer added to the circuit were reading 14-16 & 40 cm h20 respectively. Upon inspection of the inspiratory limb of the circuit co discovered only a pinpoint opening in the blue plastic connector instead of the usual quarter size opening. The circuit was changed and the pt had no adverse outcome. There was significant airflow obstruction with inspiration which could have caused morbidity. Note: hole enlarged after the above event.

Narrative Key: 21392769

General Information About The Event

Date of event: 1997-04-28

Date initial reporter provided information: 1997-04-29

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: User Facility report

Is reporter a health professional: Y

Initial reporter occupation: Physician

Submitted copy of report to FDA: No

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Vital signs, Adult circle breathing circuit 40 11/101cm

Device Event Key: 98520

FDA Product Code Classification: CAI

Model Number: *

Catalog Number: *

Lot Number: 0444

Expiration Date of Device:

Age of Device: NA

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: *

Evaluation By Manufacturer

Device Available For Evaluation: Device was returned to manufacturer

Date Returned to Manufacturer: 19970509

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

One or more cracks in grey plastic surrounding filter material. Water flows through these cracks, fills the chamber and causes the heater to heat improperly. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.

Narrative Key: 5377

General Information About The Event

Date of event:

Date initial reporter provided information: 1994-07-28

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: *

Report is about the quality, performance, or safety of a device: *

Source

Report source: User Facility report

Is reporter a health professional:

Initial reporter occupation:

Submitted copy of report to FDA:

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Transfer chamber,

Device Event Key: 9652

FDA Product Code Classification:

Model Number:

Catalog Number: 9000

Lot Number: 8382 (SUSPECT MORE THAN 1 LOT#

Expiration Date of Device:

Age of Device:

Device Operator: Invalid Data

Implanted?: *

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: No answer provided

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Patient started on hemodialysis alarms intact. Machine alarmed, tested for blood in dialysate positive. Hemodialysis stopped no blood returned to patient per hcp. Ebl 250cc per hcpdevice labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was destroyed/disposed of.

Narrative Key: 614

General Information About The Event

Date of event: 1992-06-29

Date initial reporter provided information: 1992-07-08

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: Distributor report

Is reporter a health professional: U

Initial reporter occupation: Unknown

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Same as above, Dialyzer

Device Event Key: 956

FDA Product Code Classification: KDI

Model Number: N/A

Catalog Number: 01-2114

Lot Number: 2-0515-11

Expiration Date of Device:

Age of Device:

Device Operator: Other

Implanted?: N

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Resident was in bed with both siderails in "up" position. Nursing assistant heard a noise and went into resident's room. Resident was lying on the floor with left arm stuck between the matress frame and siderail; resident was sent to hospital and received treatment for broken arm. Siderail was evaluated in "up" position - siderail lock is in working orderdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: storage/shipment, none or unknown, other. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, invalid data. Invalid data - on device destroyed/disposed of status.

Narrative Key: 3

General Information About The Event

Date of event: 1992-02-20

Date initial reporter provided information: 1992-02-21

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: User Facility report

Is reporter a health professional:

Initial reporter occupation:

Submitted copy of report to FDA:

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - N/a, Manual hospital bed

Device Event Key: 8

FDA Product Code Classification: FNJ

Model Number: 720

Catalog Number: N/A

Lot Number: N/A

Expiration Date of Device:

Age of Device:

Device Operator: Other Caregivers

Implanted?: N

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

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