BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOSET 100ML CASSETTE

    MDR report key: 24131305 · Received January 21, 2026

    Report

    Report Number
    MW5182544
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 13, 2026
    Report Date
    January 14, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CONNECTION FAILURE OCCURRED BETWEEN AN AVOSET 100ML CASSETTE RESERVOIR (12222-000-0002) AND THE MICROBORE 66" EXTENSION SET (12222-000-0016). THE SITE OF THE LEAK OCCURRED AT PART "C" OUTLINED IN THE ATTACHED PHOTO. THE LEAK CAUSED THE POUCH THE MEDICATION WAS HELD IN TO BE COMPLETELY SATURATED. PATIENT REQUIRED AN UNPLANNED TRIP BACK TO THE CANCER CENTER FOR DISCONNECT AND RECONNECTION TO A NEW DOSE OF CHEMOTHERAPY FOR COMPLETION OF THERAPY. AVOSET 100ML MEDICATION RESERVOIR (12222-000-0002); LOT: 1815.280624; EXP: 9/28/2026 AVOSET MICROBORE INFUSION SET (12222-000-0016); LOT: 1386.2606.14; EXP:9/26/26. PT CODE: 4582. DEVICE CODES: 2900, 1250. REF REPORT: MW5182545.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188717 AVOSET 100ML CASSETTE PUMP, INFUSION FRN EITAN MEDICAL LTD. 1815.280624

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female