BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTREAM

    MDR report key: 22736701 · Received August 7, 2025

    Report

    Report Number
    22736701
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    December 3, 2024
    Report Date
    July 24, 2025
    Manufacturer
    MEDICAL SPECIALTIES DISTRIBUTORS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NEW 0.28ML, 0.2 MICRON DISC FILTER UNABLE TO PROPERLY CONNECT TO IV TUBING. CAUSED DELAY IN CARE FOR A PT. W/ [PATIENT WITH] AMIODARONE DRIP- TRIED 3 DIFFERENT FILTERS AND ALL WERE UNABLE TO WORK AS INTENDED. REF FOR ITEM: MSF475. LOT # 14149982.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940759 MEDSTREAM SET, ADMINISTRATION, INTRAVASCULAR FPA MEDICAL SPECIALTIES DISTRIBUTORS, INC. MSF475 14149982

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male