JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
Received Feb 7, 2017 · Event occurred Jan 27, 2017
Report 9680904-2017-00099 · MDR key 6307076
Device
Generic name
Tray, Surgical, Needle
Manufacturer
Carefusion, IncModel number
DJ4011XLot number
0000987427
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. (B)(4).
Description of Event or Problem
SALES REP REPORTED VIA EMAIL: THE HANDLE BROKE OFF THE NEEDLE WHILE THE NEEDLE WAS IN THE PATIENT'S PELVIS. WE WERE ABLE TO GET THE NEEDLE OUT WITH VICE GRIPS AND NO HARM WAS DONE TO THE PATIENT.
Additional Manufacturer Narrative
(B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION. ONE (1) SAMPLE FROM LOT #0000987427 WAS RECEIVED FOR EVALUATION. DURING VISUAL ANALYSIS FAILURE MODE COULD BE CONFIRMED SINCE THE HANDLE WAS DETACHED FROM THE NEEDLE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. ¿LOT#0000987427 WAS MANUFACTURED ON 01-SEP-2016. DEFECTIVE COMPONENT: MOST PROBABLE CAUSE OF FAILURE MODE REPORTED COULD BE RELATED WITH MATERIAL PROVIDED FROM (B)(4). A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) WAS SENT TO THE SUPPLIER ((B)(4)). THIS FAILURE MODE WILL BE ENTERED INTO THE COMPLAINT TRACKING SYSTEM AND TRACKED & TRENDED FOR FUTURE OCCURRENCES OF ANY SIMILAR FAILURE MODES.