FRESH WHOLE BLOOD TRANSFUSION SET

Additional Manufacturer Narrative

COMBAT MEDICAL INITIATED RECALL 300825869422DEC2020R001 FOR THE REPORTED ISSUE. THE COMPLAINT WAS REPORTED WHILE FOLLOWING UP WITH CUSTOMERS ON OUR RECALL CUSTOMER LIST. THIS WAS IDENTIFIED AT A TRAINING OPERATION USING MANIKINS. NO PATIENT INVOLVEMENT. INITIAL MDR ASSESSMENT WAS COMPLETED AND DETERMINED NOT TO BE REPORTABLE BASED ON CUSTOMER USAGE (TRAINING EXERCISE) AND NO PATIENT IMPACT. HOWEVER, A FIELD ACTION WAS INITIATED AND IN AN ABUNDANCE OF CAUTION WE REEVALUATED OUR MDR ASSESSMENT AND ARE FILING THIS REPORT. COMBAT MEDICAL RECEIVED A COMPLAINT THAT THE BLOOD PACK NEEDLE WERE FOUND BENT UPON OPENING THE CONVENIENCE KIT. THE ISSUE WAS DISCOVERED TO BE ONE COMPONENT (A STAND ALONE DEVICE) WITHIN THE CONVENIENCE KIT: BLOOD PACK, SINGLE UNIT, R80-808. INVESTIGATION HAS SHOWN THAT THE CURRENT ASSEMBLY PROCESS HAS THE POTENTIAL OF BENDING/DISCONNECTING THE NEEDLES USED IN THE AFFECTED KITS. THE INFLUENCE OF THE VARIATION OF THE NEEDLE POSITION WITHIN THE COMPONENT (BLOOD PACK, SINGLE UNIT, 450 ML (R80-808)), COUPLED WITH THE MANUAL ASSEMBLY PROCESS OF FOLDING THE BLOOD PACK IS CAUSING NEEDLE DAMAGE IN THE FINISHED PRODUCT.

Description of Event or Problem

COMBAT MEDICAL INITIATED A RECALL OF BLOOD PACK 450ML. DURING THE PROCESS OF CALLING CUSTOMERS ON OUR RECALL CUSTOMER LIST TO REQUEST PRODUCT RETURN, A CUSTOMER COMMUNICATED THAT THEY HAD OBSERVED A BENT NEEDLE DURING A TRAINING SESSION WITH A MANIKIN. THERE WAS NO PATIENT INVOLVEMENT.