BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 25MM NEEDLE SET + STABILIZER(B

    MDR report key: 10390614 · Received August 11, 2020

    Report

    Report Number
    3011137372-2020-00166
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 17, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS

    Description of Event or Problem · 1

    THE REPORT STATES: ON (B)(6) 2020 I HAD RESPONDED TO CARDIAC ARREST IN PEMBROKE (20-0265). ATTEMPTED TO PLACE I0 25MM-BLUE NEEDLE IN THE PATIENT'S TIBA. THE I0 WAS PLACED, BUT I WAS UNABLE REMOVE THE NEEDLE FROM THE CATHETER. THE NEEDLE CAME OUT APPROXIMATELY 1/2, INCH AND WOULD NOT GO ANY FURTHER. A SECOND I0 WAS PLACED WITHOUT ISSUE. DURING THE TRANSPORT THE I0 THAT WE HAD A FAILURE IN WAS SOMEHOW DISLODGE FROM THE PATIENT, WHICH I SAVED AND GAVE TO YOU FOR REVIEW. IT IS BELIEVED THAT THIS I0 NEEDLE CAME FROM LOT# 6759633.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854318 EZ-IO 25MM NEEDLE SET + STABILIZER(B NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL 6759633

    Patients

    Seq Age Sex Outcome Treatment
    1