JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP

Additional Manufacturer Narrative

(B)(4)-UPON COMPLETION OF INVESTIGATION A FOLLOW UP EMDR WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

UPON CLEANING INSTRUMENT TRAY FOLLOWING DIFFICULT BONE MARROW ASPIRATION, THE RN NOTED THAT ONE OF THE JAMSHIDI NEEDLES ( IDENTIFIED ABOVE) WAS NOTABLY SHORTER THAN USUAL. THE END OF THE OUTER SECTION WAS APPROXIMATELY 3 CM SHORTER THAN A COMPARISON NEEDLE OF THE SAME PRODUCT CODE AND LOT NUMBER. THE END WAS ALSO BENT. NO NEEDLE PIECE COULD BE LOCATED. PATIENT IS BEING FOLLOWED IN CASE PIECE BROKE OFF DURING PROCEDURE. NOTICED DURING/AFTER PROCEDURE. ON (B)(6) 2016: HAS THE PIECE OF NEEDLE SINCE BEEN LOCATED? NO. PRIOR TO INITIATING PROCEDURE, WAS THE JAMSHIDI NEEDLE CHECKED FOR ANOMALIES? PRIOR TO THE PROCEDURE THERE WAS NO ANOMALIES ON THE JAMSHIDI NEEDLE AS PER THE ATTENDING PHYSICIAN. TO DATE, HAS PATIENT HAD IMAGING TO RULE OUT RETAINED NEEDLE? NO THERE WERE NO CONCERNS REGARDING THE PROCEDURE, NO FURTHER INVESTIGATIONS WERE PERFORMED. (SEE ALSO RESPONSE TO NEXT QUESTION). HAS PATIENT REQUIRED ANY ADDITIONAL INTERVENTION OR MEDICAL ATTENTION AS A RESULT OF POSSIBLE RETAINED NEEDLE? "THE PATIENT AND HER DAUGHTER CAME TO MY OFFICE ON (B)(6) 2016 FOR FOLLOW UP, I TOLD THEM THAT THE PROCEDURE WAS TECHNICALLY DIFFICULT AND THE TIP OF THE JAMSHIDI NEEDLE WAS MISSING, THE PATIENT DENIED ANY PAIN ON THE SITE OF THE BIOPSY.

Additional Manufacturer Narrative

(B)(4). ONE (1) SAMPLE FROM LOT #0000694947 WAS RECEIVED FOR EVALUATION. DURING VISUAL ANALYSIS FAILURE MODE COULD BE CONFIRMED SINCE THE NEEDLE 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 # 0000694947 WAS MANUFACTURED ON 08/28/2014. CONCLUSION(S): SUPPLIER- DEFECTIVE COMPONENT: MOST PROBABLE CAUSE OF FAILURE MODE REPORTED COULD BE RELATED WITH MATERIAL PROVIDED FROM OUR SUPPLIER. WE HAVE ISSUED A SUPPLIER CORRECTIVE ACTION REQUEST. TO DATE WE ARE WAITING ON RESPONSE.