BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL INC

    MDR report key: 9362415 · Received November 22, 2019

    Report

    Report Number
    9362415
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 25, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MEDICATION DRIP TUBING SET CAME APART AT CONNECTION OF PLASTIC SPIKE & TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157246 ICU MEDICAL INC STOPCOCK, I.V. SET FMG ICU MEDICAL, INC. 3617115

    Patients

    Seq Age Sex Outcome Treatment
    1