BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVANTICS® DEVICE SWAB

    MDR report key: 24003072 · Received January 8, 2026

    Report

    Report Number
    24003072
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 12, 2025
    Report Date
    December 12, 2025
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STAFF WAS USING THE PREVANTICS TO CLEAN THE CHEMO TUBING PRIOR TO ATTACHING AND NOTICED THE WIPE WAS DRY. AFTER INSPECTION, MULTIPLE PACKAGES OPENED AND DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63386 PREVANTICS® DEVICE SWAB PAD, ALCOHOL, DEVICE DISINFECTANT LKB PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. B19600 100000034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown