BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACP KIT SERIES I

    MDR report key: 7321372 · Received March 7, 2018

    Report

    Report Number
    1220246-2018-00080
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ARTHREX INC.
    Product Code
    FMF
    UDI-DI
    00888867001824
    PMA / PMN Number
    BK070069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT DURING A BLOOD DRAW FOR A PRP INJECTION THE BIGGER SYRINGE WAS PRIMED AND CHECKED AND THE SMALL SYRINGE FELL-OFF CAUSING THE WHOLE BLOOD TO LEAK OUT. THE PRP WAS NOT INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165046 ACP KIT SERIES I SYRINGE, PISTON FMF ARTHREX INC. 718875528 00888867001824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other