BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 511171 · Received February 5, 2004

    Report

    Report Number
    MW1031103
    Event Type
    Malfunction
    Date Received
    February 5, 2004
    Date of Event
    January 15, 2004
    Report Date
    January 27, 2004
    Manufacturer
    ICU MEDICAL
    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

    BLOOD TUBING LEAKING AT CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL BLOOD TUBING BRZ ICU MEDICAL MFG# B9282 *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other