BEUDAMED
    FDA Adverse Event Other Summary report: N

    I.V. BLOOD ADM. SET

    MDR report key: 436581 · Received January 2, 2003

    Report

    Report Number
    2025816-2002-00033
    Event Type
    Other
    Date Received
    January 2, 2003
    Date of Event
    October 28, 2002
    Report Date
    December 16, 2002
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    BRZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NURSE ADMINISTERING CHEMO THERAPEUTIC AGENT NOTICED THE SET WAS LEAKING AT THE BOND BETWEEN THE BACKCHECK VALVE AND TUBING. THE NURSE WAS EXPOSED TO THE AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I.V. BLOOD ADM. SET 011-C6006 BRZ ICU MEDICAL, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA