BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 23198851 · Received October 1, 2025

    Report

    Report Number
    MW5176872
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Report Date
    September 29, 2025
    Manufacturer
    PHILLIPS-MEDISIZE A/S
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTING NEEDING TO CHECK STATUS ON THE PUMP AS THE ONE THEY HAVE IS GOING OUT. DETAILS NOT REPORTED. UNKNOWN IF THE PRODUCT IS ON HAND FOR RETURN. UNKNOWN IF THE PATIENT MISSED A DOSE. UNKNOWN IF THE MD IS AWARE. UNKNOWN IF THE PATIENT EXPERIENCED AN ADVERSE EVENT. PRODUCT LOT NUMBER IS UNKNOWN. DOSE/ FREQUENCY/ROUTE OF ADMINISTRATION: USE AS DIRECTED WITH VYALEV. NO FURTHER INFORMATION, DATES, OR DETAILS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313094 PUMP VYAFUSER KIT PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male NOURIANZ| VIAL ADAPTER VENTED TRNSFR| VYALEV SDV