BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACP KIT SERIES I

    MDR report key: 9363968 · Received November 22, 2019

    Report

    Report Number
    1220246-2019-01429
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 22, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    FMF
    UDI-DI
    00888867001824
    PMA / PMN Number
    BK070069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS NOT CONFIRMED. AS RECEIVED, THE INNER PLUNGER WAS DISASSEMBLED FROM THE REST OF THE DEVICE. NO ABNORMALITY WAS OBSERVED, UPON REASSEMBLY THE DEVICE WAS FOUND TO FUNCTION AS EXPECTED WITH NO LEAKS. A LIKELY CAUSE IS LOOSENING OF THE INNER PLUNGER PRIOR TO OR DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING A INTRAOSSEOUS BIOPLASTY THE ACP KIT, ABS-10011, CAME APART. THE NURSE STARTED TO DRAW BLOOD FROM THE PATIENT FOR PRP HYDRATION OF DBM. THE PLUNGER WAS DRAWN BACK AND THE DEVICE FELL APART IN HAND AND ON THE FLOOR. NO PATIENT HARM. ADDITIONAL INFORMATION OBTAINED ON 11/06/2019: STAFF WAS WEARING STERILE GLOVES WHEN DRAWING BACK ON THE ACP SYRINGE FROM A VEIN IN THE FOREARM DURING SURGERY. THE INNER PLUNGER FELL OUT OF THE SYRINGE AND LANDED ON THE FLOOR ALONG WITH ALL BLOOD THAT HAD BEEN COLLECTED. STAFF PUT ON STERILE GLOVES AND USED A COMBINATION OF CLOTHS AND DISINFECTANT WIPES KEPT IN THE OPERATING ROOM TO CLEAN UP THE FLOOR. ALL MATERIALS USED TO COLLECT THE BLOOD WERE DISPOSED OF IN TRASH RECEPTACLES IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159061 ACP KIT SERIES I SYRINGE, PISTON FMF ARTHREX, INC. ACP KIT SERIES I 910792826 00888867001824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other