BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNBRANDED

    MDR report key: 22122783 · Received June 2, 2025

    Report

    Report Number
    22122783
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 19, 2025
    Report Date
    May 21, 2025
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    KPE
    UDI-DI
    00848340000027
    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

    WE JUST RECENTLY PURCHASED THIS PRODUCT TO USE FOR REMOVING MEDICATION FROM GLASS VIALS ¿ IT IS SUPPOSED TO BE MORE ASEPTIC THAN REMOVING THE RUBBER STOPPER ON THE MEDICATION VIAL, HOPEFULLY HELPING US REDUCE RISK OF INFECTION. THE PRODUCT IS DIFFICULT TO USE. IT¿S VERY HARD TO INSERT IT INTO THE RUBBER VIAL STOPPER ¿ IT HAS A POINTY TIP, BUT IT¿S VERY HARD TO PIERCE THE RUBBER WITH IT. ALSO, IN THE PROCESS IT CORES OUT PIECES OF RUBBER, LEAVING RUBBER FLOATING IN THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642687 UNBRANDED CONTAINER, I.V. KPE ADVANCE MEDICAL DESIGNS, INC. 10-106 41219C4528 00848340000027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown