BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-IO 45MM NEEDLE

    MDR report key: 4289017 · Received November 11, 2014

    Report

    Report Number
    3004526033-2014-00017
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE EZ-IO WAS PLACED INTO THE RIGHT TIBIA OF A MALE PATIENT WITH EXTREMELY LIMITED ACCESS IN THE EMERGENCY DEPARTMENT ON (B)(6) 2014. HE WAS SENT TO THE ACU AND WAS BEING DISCHARGED ON (B)(6) 2014. A FELLOW IV NURSE AND A RN FROM THE PICC TEAM WENT TO REMOVE THE IO (STILL WITHIN THE 24 HOUR WINDOW). THEY ATTACHED THE 10CC SYRINGE, PULLED UP WITH A COUNTER-CLOCKWISE MOTION, AND THE HUB SEPARATED FROM THE NEEDLE AND LEAVING THE BARE NEEDLE STICKING OUT OF THE PATIENT. AS A RESULT, THE CLINICIANS WERE ABLE TO PULL THE NEEDLE OUT WITH THE USE OF A HEMOSTAT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727061 EX-IO 45MM NEEDLE EX-IO INTRAOSSEIOUS INFUSION SYSTEM FMI VIDACARE CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1