BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PPN IV TUBING

    MDR report key: 23989625 · Received January 7, 2026

    Report

    Report Number
    23989625
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    November 2, 2025
    Report Date
    November 10, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PPN [PERIPHERAL PARENTERAL NUTRITION] TUBING LEAKING JUST BELOW THE DRIP CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49378 PPN IV TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male