VALKYRIE LOW TITER TYPE O WHOLE BLOOD KIT

Additional Manufacturer Narrative

THIS WAS IDENTIFIED AT A TRAINING OPERATION WITHIN THE US MILITARY. 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. ACTUAL PART NUMBER AND LOT NUMBER ARE UNKNOWN. THERE ARE TWO STYLES OF VALKYRIE KITS (VALKYRIE LTOWB COLLECTION SET OR VALKYRIE LTOWB ADMINSTRATION SET) 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

NEEDLES IN THE VALKYRIE KITS WHERE IDENTIFIED AS BEING BENT DURING A TRAINING EXERCISE.