BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, HYPODERMIC, SINGLE LUMEN, INTRA-OSSEOUS SYSTEM

    MDR report key: 5179982 · Received October 27, 2015

    Report

    Report Number
    5179982
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    July 30, 2015
    Report Date
    September 23, 2015
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ON A CARDIAC ARREST CALL, THE INTRAOSSEOUS (IO) SEAL WAS BROKEN AND THE IO DRILL PULLED OUT WITH THE TRIGGER COVER IN PLACE. THE IO DRILL WAS FOUND TO BE DEAD AND UNABLE TO BE USED TO OBTAIN ACCESS. THE PATIENT DID NOT HAVE IV ACCESS. ONCE THE QUICK RESPONSE VEHICLE (QRV) ARRIVED ON SCENE THE IO IN THE QRV WAS USED TO OBTAIN IO ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710736 NEEDLE, HYPODERMIC, SINGLE LUMEN, INTRA-OSSEOUS SYSTEM FMI

    Patients

    Seq Age Sex Outcome Treatment
    1