BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE INJECTION GUN -B.I.G--ADULT

    MDR report key: 2893959 · Received December 27, 2012

    Report

    Report Number
    MW5028405
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 24, 2012
    Report Date
    December 27, 2012
    Manufacturer
    WAISMED USA
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH ACUTE LOSS OF CONSCIOUSNESS, RAPID RESPONSE CALLED, INTRAOSSEOUS DEVICE PLACED IN LEFT TIBIAL PLATEAU FOR EMERGENCY ACCESS FOR FLUIDS AND MEDICATIONS. WHEN DEVICE WAS REMOVED 24 HRS LATER, THE SURGICAL STAINLESS STEEL CANNULA SNAPPED OFF 1.7 MM INSIDE THE BONE, LEAVING APPROXIMATELY 1/2 OF THE LENGTH OF THE STAINLESS STEEL CANNULA INSIDE THE BONE. IT IS UNCLEAR AT THIS POINT AS TO WHETHER THE FAILURE IS ATTRIBUTABLE TO A FLAWED DEVICE. IT IS CLEAR THAT THE RED STABILIZATION DEVICE (WHICH ACTS AS A SAFETY DEVICE, A STABILIZATION DEVICE TO STABILIZE THE CANNULA IN THE BONE, AND AS A REMOVAL DEVICE) WAS NOT USED WITH THIS PT AS THE DEVICE HAS BEEN INADVERTENTLY DISCARDED IMMEDIATELY AFTER THE DEVICE WAS PLACED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE INJECTION GUN -B.I.G--ADULT BIG FMI WAISMED USA ADULT-B.I.G 3025

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other