BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESH WHOLE BLOOD TRANSFUSION SET

    MDR report key: 11158710 · Received January 13, 2021

    Report

    Report Number
    3008258694-2021-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    September 9, 2020
    Report Date
    January 12, 2021
    Manufacturer
    COMBAT MEDICAL SYSTEMS LLC
    Product Code
    POQ
    UDI-DI
    M68980801020
    Removal / Correction Number
    300825869422DEC2020R001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. COMBAT MEDICAL RECEIVED A COMPLAINT THAT THE BLOOD PACK NEEDLES 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 · 1

    NEEDLES IN THE DONOR KITS ARE BENT AND ONE DISCONNECTED FROM THE BAG WHEN THE CORPSMAN ATTEMPTED TO UNCAP THE NEEDLE DURING A TRAINING EXERCISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54657 FRESH WHOLE BLOOD TRANSFUSION SET CONVENIENCE KIT POQ COMBAT MEDICAL SYSTEMS LLC 2 MFG3302 M68980801020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other