BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO/DUO-VENT

    MDR report key: 21525600 · Received March 5, 2025

    Report

    Report Number
    21525600
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 11, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIMARY RN (REGISTERED NURSE) REPORTED THAT WHILE SHE WAS UNHOOKING TUBING FROM PERIPHERAL IV, THE END OF THE PRIMARY TUBING BROKE OFF INTO THE NEEDLELESS END OF THE PERIPHERAL IV NEEDLESS ADAPTER ON J-LOOP. PLASTIC PIECE WAS INTACT AND REMOVED WITH FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374820 CLEARLINK/CONTINU-FLO/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2C8541 R24G20048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown