(B)(4) . ALTHOUGH WE HAVE ESTABLISHED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT, WE ARE REPORTING IT OUT OF CAUTION TO BE IN COMPLIANCE WITH 21CFR PART 803 DUE TO THE FATAL INCIDENT. BASED ON THE INFORMATION PROVIDED BY DONOR CENTER, THERE WAS NO RECORD OF ANY OF THE PRODUCTS/ LOTS USED DURING DONATION HAVING HAD ANY DEFECTS OR NOTED ISSUES. MEDICAL DEPARTMENT FROM DONOR CENTER HAD DETERMINED THAT THE FATALITY WAS UNRELATED TO THE DONATION. JMS WINGEATER A.V.FISTULA NEEDLE WAS ONLY ASSOCIATED WITH THE EVENT. FROM RESERVE SAMPLE EVALUATION AND DEVICE HISTORY RECORD REVIEW, THERE WAS NO ABNORMALITY FOUND ON THE REPORTED LOT NUMBER. THE PRODUCTS MET THE QA SPECIFICATIONS PRIOR RELEASING IT TO THE MARKET. THERE WAS NO MALFUNCTION ON THE NEEDLE ITSELF. LASTLY, JMS WILL CONTINUE TO MAINTAIN GOOD QUALITY OF OUR PRODUCTS AND ENSURE THAT ONLY GOOD QUALITY PRODUCTS ARE DELIVERED TO CUSTOMERS. WE WILL CONTINUE TO WORK WITH OUR CUSTOMERS TO IMPROVE OUR PRODUCTS QUALITY. NOT RETURNED TO MANUFACTURER.
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Patient 1
DONOR EXPERIENCED A HEART ATTACK WHICH PROVED FATAL FOLLOWING A DONATION AT THE FACILITY, (B)(6) ON (B)(6) 2017. THE CENTER DID NOT HAVE ANY RECORD FOR THE PRODUCTS/ LOTS USED DURING DONATION HAVING ANY DEFECTS OR NOTED ISSUES. AS PART OF THEIR INVESTIGATION, THE CENTER WAS REQUESTING DOCUMENTATION FROM THE SOFT GOODS MANUFACTURER IF THERE IS ANY ISSUE WITH THE LOTS OF ITEMS USED DURING THE DONOR'S DONATION. THE ACTUAL JMS NEEDLE HAD BEEN DISPOSED.