BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO

    MDR report key: 2770848 · Received September 7, 2012

    Report

    Report Number
    2770848
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 7, 2012
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    VISITOR HAD A WITNESSED CARDIAC ARREST IN THE HOSPITAL LOBBY AND WAS RESUSCITATED DURING THE CODE BLUE. AN INTRAOSSEOUS DEVICE (IO) WAS PLACED DURING RESUSCITATION. AFTER THE PATIENT WAS TRANSFERRED TO ICU, THE RN NOTED BLOOD AND IV FLUID LEAKING FROM THE IO HUB AT THE INSERTION SITE. THE IO HUB APPEARED TO BE CRACKED AND DURING AN ATTEMPT TO DISCONTINUE THE LINE, THE PLASTIC ADAPTER BROKE COMPLETELY OFF (LEAVING THE IO NEEDLE EXPOSED). AN ORTHOPEDIC SURGEON WAS CONSULTED AND THE IO NEEDLE WAS SUCCESSFULLY REMOVED AT THE BEDSIDE AND THE SITE WAS SUTURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR