BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 22929884 · Received September 2, 2025

    Report

    Report Number
    22929884
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 9, 2025
    Manufacturer
    FRESENIUS KABI AG
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BETWEEN [DATE REDACTED] AND [DATE REDACTED] -- APPROXIMATELY 20 DAYS, THERE WERE 28 REPORTS OF IV TUBING FAILURES. THE FOLLOWING ARE THE ISSUES: SET-0014-1: AIR IN LINE-1. SET-0032-1: AIR IN LINE-3, ALARMING-2, BROKEN-1, CASSETTE LEAKING-6, CRACKED LUER LOCK-7, MISSING METAL STRIP ON CARTRIDGE-1, NO BACK-PRIME-2, LEAKING TUBING-4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864829 IVENIX, INC. SET, ADMINISTRATION, INTRAVASCULAR FPA FRESENIUS KABI AG SET-0014-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown