BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 25MM NEEDLE (BOX OF 5)

    MDR report key: 10864567 · Received November 18, 2020

    Report

    Report Number
    3011137372-2020-00245
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 28, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. FUNCTIONAL TESTING AND INVESTIGATION ACTIVITIES CANNOT BE CONDUCTED. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. THE DEVICE HISTORY FILE IS NOT AVAILABLE FOR REVIEW. THE CERTIFICATE OF COMPLIANCE CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE (B)(4) QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY (B)(4)) IN ACCORDANCE WITH THE FDA QSR AND ISO 13485:2003.

    Description of Event or Problem · 1

    REPORTED ISSUE: EMS INSERTED IO WITH BONE DRILL IN LEFT TIBIA. INSERTION OF NEEDLE AND PLACEMENT PERFORMED APPROPRIATELY HOWEVER, THE NEEDLE PORTION WAS FUSED IN THE CATHETER HOUSING AND COULD NOT BE REMOVED. EMS HAD ANOTHER MEDIC TRY TO UNSCREW THE NEEDLE, WHICH HE COULD NOT. EMS INSERTED 2ND IO IN THE PATIENT'S RIGHT TIBIA WHICH PROGRESSED APPROPRIATELY. EMS FLUSHED THE SITE WITH 20 ML NS AND PLACED PRESSURE BAG ON 1000 ML NS HUNG WIDE OPEN. EMS MADE A POINT TO SHOW ED THE FAILED ATTEMPT ON THE LEFT TIBIA AND EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327971 EZ-IO 25MM NEEDLE (BOX OF 5) NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL 6323656

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR