JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

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 STATED VIA EMAIL: THE USER WAS TRYING TO GET A SAMPLE OUT OF THE JAMSHIDI NEEDLE AND STUCK HER THUMB WITH THE NEEDLE (ON 2 DIFFERENT DATES). ADDITIONAL INFORMATION RECEIVED 19SEPT2016: APPROX 2 WKS LATER. SAME SCENARIO. (SEE (B)(4): DR. (B)(6) PERFORMED BONE MARROW PROCEDURE. WAS HAVING DIFFICULTY REMOVING SAMPLE FM CORING NEEDLE. WAS REALLY JAMMED IN. WAS PUSHING FOR APPROX. 10 MINS AND COULD NOT GET IT TO BUDGE. PASSED IT OFF TO HIS MA WHO CONTINUED TO WORK WITH IT AND IN THE PROCESS SHE SOMEHOW NICKED/SCRAPED HERSELF W/BONE MARROW NEEDLE. WAS SUCCESSFUL IN GETTING CORE SAMPLE OUT. SAME LOT OF BONE MARROW KITS. SAME PHYSICIAN, SAME MA. ONLY DIFFERENCE, THIS TIME MA WAS AWARE OF STICK. OF NOTE BOTH TIMES PROTOCOL WAS FOLLOWED. MA WENT TO HR FOR HEALTH SCREENING FOLLOW UP. MA WAS INTERVIEWED REGARDING BONE MARROW POLICY AND PROCEDURE W/EMPHASIS ON SAFETY.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION. WITH NO SAMPLE OR PICTURE TO EVALUATE, THE INVESTIGATION WAS UNABLE TO CONFIRM THIS FAILURE MODE. THE DHR WAS REVIEWED AND NO ANOMALIES WERE FOUND DURING THE DATE OF PRODUCTION; THEREFORE THIS COMPLAINT COULD NOT BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT IS PRODUCT MISUSE, THE DHR DID NOT SHOW ANY MANUFACTURING RELATED DEFECTS AND THE TREND REPORT DID NOT REVEAL ANY ADVERSE TRENDS. THE DHR WAS REVIEWED AND NO ANOMALIES WERE FOUND DURING THE DATE OF PRODUCTION; THEREFORE THIS COMPLAINT COULD NOT BE CONFIRMED.