BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 11663526 · Received April 14, 2021

    Report

    Report Number
    11663526
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 9, 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 CENTRAL LINE. THIS RN USED THE DOUBLE STOPCOCK METHOD AND ATTACHED A YELLOW STOPCOCK WITH A BLUE STOPCOCK BEHIND THE YELLOW STOPCOCK TO THE NEUTRON CAP. THE CAP BECAME FILLED WITH BLOOD AND THIS RN COULD NOT FLUSH THE BLOOD THROUGH THE NEUTRON CAP. THEN THIS RN CHANGED THE CAP. THE CAP WAS DISPOSED OF. THERE WAS NO DETECTABLE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561982 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. NC100 UNSURE, CURRENT: 5093657

    Patients

    Seq Age Sex Outcome Treatment
    1 7300 DA