BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL, INC.

    MDR report key: 488212 · Received September 18, 2003

    Report

    Report Number
    MW1029616
    Event Type
    Malfunction
    Date Received
    September 18, 2003
    Date of Event
    September 9, 2003
    Report Date
    September 18, 2003
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV BAG OF NORMAL SALINE INFUSING; WHEN NEW BAG HUNG AND THE BAG PLACED ON POLE, IV TUBING FELL/SEPARATED FROM WHERE IT SPIKED BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL, INC. IV TUBING - BIFUSE BLOOD SET BRZ ICU MEDICAL, INC. B9282 136859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other