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 Number: 3846
• MDR Report Key: 3846
• Date Received: 1993-01-19
• Date of Report: 1992-12-09
• Date of Event: 1992-11-03
• Date Facility Aware: 1992-11-03
• Report Date: 1992-12-09
• Date Reported to Mfgr: 1992-11-03
• Date Added to Maude: 1993-05-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: JAMSHIDI BONE MARROW BIOPSY TRAY
• Product Code: FCH
• Date Received: 1993-01-19
• Catalog Number: CAT. NO BAK3411
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3586
• Manufacturer: BAXTER HEALTHCARE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-19