JAMSHIDI BONE MARROW BIOPSY TRAY CAT. NO BAK3411

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-19 for JAMSHIDI BONE MARROW BIOPSY TRAY CAT. NO BAK3411 manufactured by Baxter Healthcare.

Event Text Entries

[20683316] On 11/3/92 a bone marrow biopsy of the right posterior iliac crest was being performed when the tip of the bone marrow needle broke off. There had been a successful aspiration completed on the left posterior iliac crest prior to attempting aspiration on the right iliac crest. The needle was successfully removed on 11/4/92 under general anesthesia. The baxter sales representative was notified. They plan to recall the lot number. It is unknown why the needle tip broke off. Device labeled for single use. Patient medical status prior to event: satisfactory 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, visual examination. Results of evaluation: telemetry failure, none or unknown. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device recalled by manufacturer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3846
MDR Report Key3846
Date Received1993-01-19
Date of Report1992-12-09
Date of Event1992-11-03
Date Facility Aware1992-11-03
Report Date1992-12-09
Date Reported to Mfgr1992-11-03
Date Added to Maude1993-05-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameJAMSHIDI BONE MARROW BIOPSY TRAY
Product CodeFCH
Date Received1993-01-19
Catalog NumberCAT. NO BAK3411
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key3586
ManufacturerBAXTER HEALTHCARE


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-01-19

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