BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACP KIT SERIES I

    MDR report key: 12569496 · Received October 4, 2021

    Report

    Report Number
    1220246-2021-03724
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    August 27, 2021
    Report Date
    October 4, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    FMF
    UDI-DI
    00888867001824
    PMA / PMN Number
    BK070069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    ON (B)(6) 2021 IT WAS REPORTED BY A SALE REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP KIT SERIES I, IS FAULTY AND LEAKED. ADDITIONAL INFORMATION 9/27/2021 ON (B)(6) 2021 IT WAS REPORTED BY A SALE REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP KIT SERIES I, FLANGE PART ON THE INNER SYRINGE DID NOT HAVE A GOOD SEAL AND ACP WAS LEAKING OUT OF THE BACK WHILE THE DOCTOR PUSHED THE PLUNGER TO INJECT. THIS WAS DISCOVERED DURING A PRP INJECTION ON (B)(6) 2021. THE PRP INJECTION WAS COMPLETED BY OPENING AND ADDITIONAL KIT AND REDRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464697 ACP KIT SERIES I SYRINGE, PISTON FMF ARTHREX, INC. ACP KIT SERIES I 1091111237 00888867001824

    Patients

    Seq Age Sex Outcome Treatment
    1