JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
Received Mar 20, 2015 · Event occurred Feb 6, 2015
Report 9680904-2015-00054 · MDR key 4619542
Device
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
DURING A BIOPSY, THE NEEDLE IS BROKEN AND A PART IS STILL IN THE PATIENT. NEED FOR SURGICAL INTERVENTION FOR EXTRACTION. NO ADDITIONAL INFORMATION PROVIDED.
Additional Manufacturer Narrative
(B)(4): FAILURE MODE COULD NOT BE CONFIRMED BECAUSE SAMPLES WERE NOT RECEIVED FOR EVALUATION. 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. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED FAILURE MODE SINCE SAMPLES WERE NOT RETURNED FOR ANALYSIS. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.
Additional Manufacturer Narrative
(B)(4): IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.