JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
Received Jun 15, 2017 · Event occurred Jun 2, 2017
Report 9680904-2017-00110 · MDR key 6644301
Device
Product problems
- Material Integrity Problem
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(4) FOLLOW UP EMDR SUBMISSION FOR DEVICE EVALUATION. ONE (1) SAMPLE FROM LOT #00001001455 WAS PROVIDED FOR EVALUATION. FAILURE MODE COULD BE CONFIRMED SINCE THE DEVICE WAS BROKEN. 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 #0001001455 WAS MANUFACTURED ON 26-SEP-2016. MOST PROBABLE CAUSE OF FAILURE MODE REPORTED COULD BE RELATED WITH MATERIAL PROVIDED FROM BD MANNFORD. A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) HAS BEEN ISSUE TO THE SUPPLIER (BD-MANNFORD). THIS FAILURE MODE WILL BE ENTERED INTO THE COMPLAINT TRACKING SYSTEM AND TRACKED & TRENDED FOR FUTURE OCCURRENCES OF ANY SIMILAR FAILURE MODES.
Additional Manufacturer Narrative
(B)(4) . A FOLLOW UP SUBMISSION WILL BE COMPLETED UPON CAREFUSION'S INVESTIGATION. (B)(4).
Description of Event or Problem
THE NEEDLE BROKE OFF IN THE PATIENT AND PATIENT HAD TO GO TO THEATRE TO HAVE NEEDLE REMOVED. PROVIDER WAS USING JAMSHIDI AND PLACED THE NEEDLE IN PATIENT'S ILIAC CREST BUT WAS HAVING TROUBLE GETTING IT OUT; HE HAD TO USE FORCE TO REMOVE AND THE HANDLE SNAPPED OFF. HE THEN USED FORCEPS TO REMOVE THE REST OF THE NEEDLE BUT IT SNAPPED AGAIN. PATIENTS CURRENT HEALTH STATUS IS FINE AND NO FURTHER INTERVENTION NEEDED.