BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO

    MDR report key: 23390405 · Received October 27, 2025

    Report

    Report Number
    23390405
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 2, 2025
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    TPN [TOTAL PARENTERAL NUTRITION] NOTED TO BE LEAKING AT DISTAL END OF FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2798790 MAXZERO SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL MZ9271 (10) 24039019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male