BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVANTICS

    MDR report key: 19508981 · Received June 11, 2024

    Report

    Report Number
    19508981
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 13, 2024
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON GOING TO DRAW BLOOD CULTURES, SEVERAL PREVANTICS SWABS WERE NOTED TO BE COMPLETELY DRIED OUT. RN COLLECTED SUPPLIES FROM MED ROOM NECESSARY TO DRAW BLOOD CULTURES. 3 PREVANTICS STICKS WERE TAKEN TO CLEANSE THE SITE. EACH OF THE 3 PREVANTICS STICKS THAT WERE OPENED WERE COMPLETELY DRIED OUT. THEREFORE, COULD NOT BE UTILIZED. EACH PREVANTICS STICK WAS OPENED AT THE BEDSIDE FOR IMMEDIATE USE, AND EACH WAS COMPLETELY DRIED OUT. EXPIRATION DATE: (SAME ON ALL 3) [REDACTED DATE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807937 PREVANTICS PAD, ALCOHOL, DEVICE DISINFECTANT LKB PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. S40750 12301093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown