JAMSHIDI NEEDLE BONE MARROW 11GX6 ASP
Received Oct 15, 2010 · Event occurred Sep 13, 2010
Report 9680904-2010-00017 · MDR key 1902453
Device
Generic name
Tray, Surgical, Needle/fsh
Manufacturer
CarefusionModel number
DJ6011XCatalog number
DJ6011X
Lot number
D09030418
Product problems
- Break
- Detachment Of Device Component
Patient
NI
- No Information
Narrative
Description of Event or Problem
THE HANDLE OF THE NEEDLE BROKE OFF WHILE INSIDE PATIENT. DOCTOR NEEDED TO USE PLIERS TO REMOVE BROKEN NEEDLE.
Additional Manufacturer Narrative
ONE SAMPLE WAS RECEIVED FOR EVALUATION AND DURING VISUAL INSPECTION IT WAS FOUND THAT THE METAL HUB OF THE CANNULA WAS SEPARATED FROM THE CANNULA. THEREFORE; WE ARE ABLE TO CONFIRM THE ISSUE REPORTED. THE CAUSE FOR THE ISSUE REPORTED IS DUE TO THE BOND PULL TEST FOR THE HUB CANNULA JUNCTION. THE TEST WAS NOT BEING PERFORMED CORRECTLY AND THEREFORE, THE RESULTS WERE THAT THE UNIT OF MEASURE WERE NOT CONSISTENT. AS CORRECTIVE ACTION, THE PROCEDURE FOR THE BOND PULL TEST HAS BEN MODIFIED AND RETRAINING OF THE PERSONNEL WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REPORTED FOUND ISSUES RELATED TO THIS FAILURE MODE DURING THE DOCUMENTATION REVIEW.