JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP

Additional Manufacturer Narrative

(B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION. FAILURE MODE COULD NOT BE CONFIRMED SINCE NO SAMPLES OR PHOTOS WERE 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. LOT #0001062440 WAS MANUFACTURED ON 14-FEB-2017. BASED ON THE INVESTIGATION RESULTS, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED FAILURE MODE SINCE SAMPLES WERE NOT RETURNED FOR EVALUATION. 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). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

Description of Event or Problem

CUSTOMER REPORTED VIA EMAIL: THE TIPS OF THE NEEDLES ARE CRUSHING DOWN WHEN THE NEEDLE ENTERS THE BONE, MAKING IT DIFFICULT TO COLLECT THE SAMPLE. PATIENT IMPACT UNKNOWN. ADDITIONAL INFORMATION RECEIVED 31MAY2017: THERE WERE NO PATIENTS INJURED DURING THE PROCEDURE. THE NURSE PRACTITIONER STUCK HER FINGER TWICE TRYING TO OBTAIN SPECIMENS, BUT THE PATIENT WAS NOT INJURED. ADDITIONAL QUERIES SENT. ADDITIONAL INFORMATION RECEIVED 31MAY2017: (B)(6). GENDER: FEMALE NEEDLE STICK PROTOCOL FOLLOWED.