BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ IO 45MM NEEDLE SET + STABILIZER

    MDR report key: 23093925 · Received September 19, 2025

    Report

    Report Number
    3011137372-2025-00345
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 17, 2025
    Report Date
    August 26, 2025
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K180395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "19-YEAR-OLD MALE POST CARDIAC ARREST. THE MEDS WERE DOCUMENTED AS IV (JUST FYI). THE PATIENT HAD ROSC PRIOR TO ARRIVAL TO US AND OUR TEAM STARTED AN IV AND WENT TO PULL THE IO OUT BY TURNING IT AS PER GUIDELINES AND THE NEEDLE WAS BROKEN OFF IN THE PATIENT'S LEFT HUMERUS. AN XRAY HERE CONFIRMED THAT THE PLACEMENT WAS IN THE HUMERAL HEAD AS INTENDED." ADDITIONAL INFORMATION REQUESTED FROM THE ACCOUNT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "19 YEAR OLD MALE POST CARDIAC ARREST. THE MEDS WERE DOCUMENTED AS IV (JUST FYI). THE PATIENT HAD ROSC PRIOR TO ARRIVAL TO US AND OUR TEAM STARTED AN IV AND WENT TO PULL THE IO OUT BY TURNING IT AS PER GUIDELINES AND THE NEEDLE WAS BROKEN OFF IN THE PATIENTS LEFT HUMERUS. AN XRAY HERE CONFIRMED THAT THE PLACEMENT WAS IN THE HUMERAL HEAD AS INTENDED." ADDITIONAL INFORMATION REQUESTED FROM THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276451 EZ IO 45MM NEEDLE SET + STABILIZER NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown