BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALKYRIE LOW TITER TYPE O WHOLE BLOOD KIT

    MDR report key: 11158748 · Received January 13, 2021

    Report

    Report Number
    3008258694-2021-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    October 21, 2020
    Report Date
    January 12, 2021
    Manufacturer
    COMBAT MEDICAL SYSTEMS LLC
    Product Code
    POQ
    Removal / Correction Number
    300825869422DEC2020R001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54659 VALKYRIE LOW TITER TYPE O WHOLE BLOOD KIT CONVENIENCE KIT POQ COMBAT MEDICAL SYSTEMS LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other