BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 20587029 · Received November 1, 2024

    Report

    Report Number
    20587029
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    August 20, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REGISTERED NURSE (RN) GETTING READY TO START AN IV FLUSHED THE J LOOP WHEN IT WAS NOTED TO HAVE A "CRACK" ON THE SIDE OF IT AND SALINE WAS LEAKING OUT OF IT. J LOOP REMOVED AND A NEW ONE PLACED AND FLUSHED SUCCESSFULLY PRIOR TO STARTING PATIENTS IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631510 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. MC33213 14058831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female