BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ IO NEEDLE

    MDR report key: 3236270 · Received July 17, 2013

    Report

    Report Number
    3236270
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    July 13, 2013
    Report Date
    July 15, 2013
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT ARRIVED TO THE ED WITH EMS WHOM HAD PLACED AN INTRAOSSEOUS ACCESS TO THE LEFT TIBIAL SITE. WHILE REMOVING THE NEEDLE WITH HEMOSTAT, SAFETY APPARATUS/CAP DETACHED FROM THE NEEDLE LEAVING THE NEEDLE SECURED IN PATIENT'S LEG. GAUZE WAS APPLIED TO THE SITE WITHOUT OOZING NOTED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330684 EZ IO NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI VIDACARE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR OTHER