BEUDAMED
    FDA Adverse Event Death Summary report: N

    WMBIG-C

    MDR report key: 2274756 · Received September 26, 2011

    Report

    Report Number
    9616791-2011-00009
    Event Type
    Death
    Date Received
    September 26, 2011
    Report Date
    September 25, 2011
    Manufacturer
    WAISMED LTD.
    Product Code
    FMI
    PMA / PMN Number
    K022415
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE ASKED THE USER TO RECEIVE THE DEVICE AND NEEDLE FOR INSPECTION. WE WILL HAVE TO WAIT FOR THE PRODUCT TO ARRIVE TO OUR FACILITIES FOR INVESTIGATION FOR OUR FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A (B)(6) PATIENT FOUND IN A CARDIAC ARREST. THE EMS AGENCY WAS UNABLE TO OBTAIN IV ACCESS THEREFORE USED THE PEDIATRIC B.I.G. DEVICE. UPON DEPLOYMENT, THE NEEDLE WENT THROUGH THE PLASTIC SURROUNDING THE DESIGNATED EXIT HOLE AND NOT THROUGH THE EXIT HOLE ITSELF. UPON ARRIVAL TO THE ER, THE HOSPITAL CREW WAS ABLE TO OBTAIN VASCULAR ACCESS. THE PATIENT DID ACHIEVE ROSC (RETURN OF SPONTANEOUS CIRCULATION) AND WAS TRANSPORTED BY AIR TO A HIGHER LEVEL CARE HOSPITAL - WHERE LATER PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WMBIG-C B.I.G. BONE INJECTION GUN FMI WAISMED LTD. WMBIG-C 4014

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death