BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 23062110 · Received September 16, 2025

    Report

    Report Number
    23062110
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PLACING PIV [PERIPHERAL INTRAVENOUS LINE] FOR BLOOD TRANSFUSION: T-CONNECTER PIECE TO PIV HAD FLUSH CONNECTED AND PREPARED FOR NEW PIV INSERTION/FLUSH. PIV INSERTED, T-CONNECTOR CONNECTED, FLUSHED WELL, SECURED PIV WITH TAPE ETC. WHEN REMOVED FLUSH THE INNER PIECE STAYED STUCK DOWN ON THE T-CONNECTOR CLAVE, AND CLAVE NO LONGER FUNCTIONAL TO CONNECT SYRINGES TO USE PIV FOR MEDS/FLUSH ETC. HAD TO TAKE PIV THAT WAS JUST DRESSED ALL THE WAY DOWN TO HUB AND FLUSH AND REPLACE T-CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286534 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. MC33150 14406995

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Female