BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO INTRAOSSEOUS DRILL NEEDLE SET (ADULT)

    MDR report key: 2145752 · Received June 26, 2011

    Report

    Report Number
    MW5021158
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    March 14, 2011
    Report Date
    June 26, 2011
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FIRE DEPARTMENT AMBULANCE (PARAMEDIC) TREATMENT OF A (B)(6) MALE IN CARDIAC ARREST INCLUDED THE USE OF A VIDACARE EZ-IO DEVICE. PARAMEDICS INSERTED THE NEEDLE SET INTO THE PATIENT'S LEG, BUT WERE UNABLE TO UNSCREW/REMOVE THE STYLET FROM THE CATHETER. THE FAILURE OF THIS DEVICE CAUSED IT TO BE UNUSABLE FOR MEDICATION ADMINISTRATION. I SPOKE WITH A REPRESENTATIVE FROM THE MANUFACTURER AFTER THE INCIDENT. I WAS TOLD THAT THEY WERE AWARE OF THE PROBLEM AND THAT IT WAS ONLY THE 5TH OR 6TH COMPLAINT. I WAS TOLD THAT IT WAS FROM "TOO MUCH GLUE" BEING USED, AND THAT IT MADE THE STYLET AND THE CATHETER "BOND" TOGETHER. I WAS TOLD THAT THERE WERE NO OTHER INCIDENTS OF THIS IN MY AREA OF THE COUNTRY, AND THAT THERE THE DEFECTIVE DEVICES WERE ON AN INDIVIDUAL BASIS - NOT SPECIFIC TO ANY LOT NUMBERS. APPROXIMATELY ONE MONTH LATER THE SAME TYPE OF INCIDENT OCCURRED IN A NEIGHBORING COMMUNITY. A "SERIOUS INCIDENT REPORT" WAS FILED WITH THE (B)(4) OFFICE OF EMERGENCY MEDICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-IO INTRAOSSEOUS DRILL NEEDLE SET (ADULT) EZ-IO FMI VIDACARE CORPORATION ADULT NEEDLE SET NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other