BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESH WHOLE BLOOD TRANSFUSION SET

    MDR report key: 11938052 · Received June 4, 2021

    Report

    Report Number
    3008258694-2021-00011
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Report Date
    May 26, 2021
    Manufacturer
    COMBAT MEDICAL SYSTEMS LLC
    Product Code
    POQ
    Removal / Correction Number
    300825869422DEC2020R001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840043 FRESH WHOLE BLOOD TRANSFUSION SET CONVENIENCE KIT POQ COMBAT MEDICAL SYSTEMS LLC 80-801 MFG3394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other