BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACP KIT SERIES I

    MDR report key: 13154455 · Received January 4, 2022

    Report

    Report Number
    1220246-2022-04239
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 17, 2021
    Report Date
    January 4, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    FMF
    UDI-DI
    00888867001824
    PMA / PMN Number
    BK070069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10011 ACP KIT HAD THE INNER SYRINGE POP OUT DURING THE BLOOD DRAW, EVEN AFTER IT WAS TIGHTENED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED 12/23/2021: THIS OCCURRED DURING A KNEE INJECTION PROCEDURE AND SURGEON COMPLETED CASE USING ANOTHER ABS-10011 KIT FROM THE SAME LOT NUMBER WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION RECEIVED 12/23/2021: DURING THE BLOOD DRAW, THE INNER SYRINGE POPPED OUT AND CAUSED A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118820 ACP KIT SERIES I SYRINGE, PISTON FMF ARTHREX, INC. ACP KIT SERIES I 1197114067 00888867001824

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown