BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLEX -GV

    MDR report key: 23597509 · Received November 19, 2025

    Report

    Report Number
    MW5179067
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 14, 2025
    Manufacturer
    MERK MILLIPORE LTD.
    Product Code
    BSN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FILTER FAILED INTEGRITY TESTING WITH BUBBLE POINT BETWEEN 35-45 PSI INSTEAD OF LABELED 50 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023813 MILLEX -GV FILTER, CONDUCTION, ANESTHETIC BSN MERK MILLIPORE LTD. SLGVM33RS 0000340077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown