BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 17984879 · Received October 23, 2023

    Report

    Report Number
    17984879
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    June 7, 2023
    Report Date
    September 5, 2023
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONCOLOGY KIT WITH CHEMOLOCK WITH RED CAP, CHEMOLOCK PORT MALFUNCTIONED. RN PUT 'MALE' PIECE ON Y-PORT OF SALINE LINE TO GIVE 5FU CHEMOTHERAPY. ABLE TO FLUSH AND GET BLOOD RETURN FOR THE FIRST 2-3MLS OF THE 5FU PUSH. THEN MET RESISTANCE AND UNABLE TO GET BLOOD RETURN. CONNECTIONS CHECKED AND NO ISSUES NOTED BUT STILL NOT WORKING. CHANGED 'MALE' PIECE OF CHEMOLOCK PORT AND NOW ABLE TO FLUSH/GET BLOOD RETURN. REF CL4136, LOT 8983871.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003121 ICU MEDICAL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL, INC. CL4136 8983871

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown