UNKNOWN

Additional Manufacturer Narrative

THIS WAS IDENTIFED AT A TRAINING OPERATION WITHIN THE US MILITARY. NO PATIENT INVOLVEMENT. REFERENCE MDR NO. 3008258694-2021-00001. 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 CONVIENENCE KIT. THE ISSUE WAS DISCOVERED TO BE ONE COMPONENT (A STAND ALONE DEVICE) WITHIN THE CONVIENENCE 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

KIT COMPONENT, BLOOD PACK 450ML LOT NUMBER FM20B14037, HAD A BENT NEEDLE WHEN KIT WAS OPENED.