BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WMBIG-A1

    MDR report key: 2500316 · Received July 5, 2011

    Report

    Report Number
    9616791-2011-00006
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 3, 2011
    Manufacturer
    WAISMED LTD.
    Product Code
    FMI
    PMA / PMN Number
    K981853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM OUR PRELIMINARY INVESTIGATION, IT APPEARS THE DEVICE WAS INSERTED SUCCESSFULLY AS THE MEDICS WERE ABLE TO ADMINISTER MEDICATION THROUGH THE IO. IT ALSO APPEARS THE DEVICE WAS ABUSED DURING MULTIPLE TRANSPORTS AND STAFF UNFAMILIAR WITH THE BIG IO DEVICE. WE HAVE REQUESTED (B)(6) HOSPITAL MAKE THE BROKEN DEVICE AVAILABLE FOR OUR INVESTIGATION, BUT THEY HAVE DELAYED THE RELEASE OF THE DEVICE TO WAISMED. WAISMED HAS ALREADY MADE A SHIPPING (CALL TAG) LABEL AND PAID FOR SHIPPING OF THE BROKEN DEVICE BACK TO WAISMED'S US REP, PERSYS MEDICAL. IN AN EMAIL DATED JULY 1, 2011, MS. (B)(6) STATES. "THEY WOULD LIKE ME TO HOLD OFF SENDING THE BIG PRODUCT... THE ISSUE IS BEING SHARED WITH SOME SPECIFIC PEOPLE IN OUR HOSPITAL AND WE ARE ALLOWING TIME FOR ALL THE INFO TO BE GATHERED." WAISMED IS CURRENTLY TRYING TO DETERMINE THE LOT NUMBER/EXPIRATION DATE OF THE DEVICE. WAISMED WILL NEED TO RECEIVE THE DEVICE IN QUESTION FOR INVESTIGATION AND FOLLOW UP REPORT. WE CONDUCT SAMPLE PULL-TESTING ON ALL OUR NEEDLES UPON RECEIVING TO STOCK (INCOMING INSPECTION).

    Description of Event or Problem · 1

    (B)(6) SERVICES WAS DISPATCHED TO A NURSING HOME FOR A (B)(6) WOMAN, IN RESPIRATORY FAILURE. THE PT RECEIVED AN IO (BIG) AND VERSED (MIDAZOLAM) THROUGH THE IO. THE PT WAS THEN TRANSPORTED TO A LOCAL HOSPITAL (B)(6). THE MEDICS STATED THE HOSPITAL STAFF SEEMED INATTENTIVE TO THE IO. AT (B)(6), THE PT WAS PLACED IN A HELICOPTER FOR TRANSPORT TO (B)(6). THERE WAS AN ISSUE WITH THE HELICOPTER AND THE PT WAS MOVED TO A SECOND HELICOPTER FOR TRANSPORT. THE PT WAS ADMITTED TO THE ICU FOR AN ACUTE MI AND A PE. THE HOSPITAL THAT REMOVED THE IO IS UNFAMILIAR WITH THE BIG AS THEY ARE AN EZ-IO FACILITY. THEY LOOKED UP ONLINE AND FOUND A NURSING ARTICLE... THAT DESCRIBED THREE MAJOR IO DEVICES, HOW TO USE THEM, AND HOW TO REMOVE THEM... THE DEVICE WAS STABILIZED IN THE PT'S LEG WITH TAPE AND GAUZE BUT NOT THE STANDARD RED SAFETY. SHE PLACED A SYRINGE ON THE DEVICE, AND SHE STATES SHE, "LIFTED UP AND TWISTED" TO REMOVE THE DEVICE. AT THAT POINT, SHE FELT SOMETHING WAS WRONG AND THE HUB AND PART OF THE SHAFT DISCONNECTED FROM THE BODY OF THE CANNULA. THEY X-RAYED THE PT'S LEG AND PER ORTHO, CONSIDERING THE PT'S STATE, THEY ARE NOT GOING TO ATTEMPT ANY FURTHER REMOVAL (WHICH MIGHT REQUIRE SURGERY...).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WMBIG-A1 B.I.G. BONE INJECTION GUN FMI WAISMED LTD. WMBIG-A1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other