BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO 45MM NEEDLE SET + STABILIZER (BOX O

    MDR report key: 4531251 · Received February 19, 2015

    Report

    Report Number
    3004526033-2015-00015
    Event Type
    Injury
    Date Received
    February 19, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 5, 2015
    Manufacturer
    VIDACARE
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED DURING A CODE BLUE. THE ER DOCTOR TOOK AN IO NEEDLE THAT HAD ALREADY BEEN PLACED, WIGGLED IT BACK AND FORTH SAYING IT WASN'T STABLE, AND PULLED THE NEEDLE OUT. THE DOCTOR PLACED THE SAME NEEDLE IN THE LEFT MID TIBIA USING THE IO DRIVER. HE WAS UNABLE TO ADMINISTER MEDS THROUGH THE NEEDLE. A FEMORAL CVC HAD BEEN PLACED AT THIS TIME AND THE PT WAS SUCCESSFULLY RESUSCITATED. TWO HOURS LATER THE RRT MANAGER REPORTED THAT THE NEEDLE HUB HAD BROKEN OFF AND THEY COULD NOT GET THE NEEDLE OUT OF THE PT WITH HEMOSTATS. THEY WERE ADVISED TO USE VICE GRIPS OF PLIERS TO TWIST AND PULL THE NEEDLE OUT. ONE HOUR LATER IT WAS REPORTED THAT THE NEEDLE BROKE OFF. 1MM OF NEEDLE WAS EXPOSED OUTSIDE THE INSERTION SITE AND HEMOSTAT WAS CONNECTED TO IT FOR STABILIZATION. IT WAS LATER REPORTED THAT AN ORTHO REMOVED THE NEEDLE AND X-RAY REVEALED THAT THE NEEDLE HAD GONE ACROSS AND EMBEDDED INTO THE OPPOSITE SIDE OF THE TIBIA. NO PT DEATH OR ADD'L COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119825 EZ-IO 45MM NEEDLE SET + STABILIZER (BOX O IZ-IO INTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention