BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 11640597 · Received April 9, 2021

    Report

    Report Number
    11640597
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 7, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS RN WAS DRAWING BLOOD FOR LABS THROUGH THE NEUTRON CAP ATTACHED TO THE PATIENT'S PORT, THE NEUTRON CAP BECAME FILLED WITH BLOOD AND THIS RN COULD NOT FLUSH THE BLOOD THROUGH THE NEUTRON CAP. THIS RN CHANGED THE NEUTRON CAP DAYS EARLIER DUE TO THE DEFECTIVE NEUTRON CAP BEING FILLED WITH BLOOD, PUTTING THE PATIENT AT RISK FOR INFECTION AND THROMBOSIS. THIS EVENT HAD NO DETECTABLE HARM. THE DEVICE MENTIONED WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537113 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. NC100 UNKNOWN, CURRENT LOT#: 5093657

    Patients

    Seq Age Sex Outcome Treatment
    1 6205 DA