BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 16013591 · Received December 20, 2022

    Report

    Report Number
    16013591
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 14, 2022
    Report Date
    November 29, 2022
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TPN TUBING FILTER SENT FROM PHARMACY CAME APART AT FILTER SECTION X2. PARTS NOT SUPPOSED TO COME APART AT THIS SECTION. LOT NUMBER BAG 5881552. REQUESTED DIFFERENT LOT NUMBER FROM PHARMACY FOR 3RD CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701551 ICU MEDICAL STOPCOCK, I.V. SET FMG ICU MEDICAL, INC. B1115 5881552

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown