BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SANI-CLOTH GERMICIDAL DISPOSABLE WIPE

    MDR report key: 8743995 · Received June 28, 2019

    Report

    Report Number
    8743995
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 16, 2019
    Report Date
    June 20, 2019
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO NEW CANISTERS OF THE SANI-CLOTH GERMICIDAL WIPES WERE OPENED TO BE USED IN THE ER. WHEN THE SEAL WAS PEELED OFF THE TOP, THEY NOTICED BROWN/RUSTY SPOTS OVER THE TOP OF THE WIPES. SOME OF THEM WERE STUCK TO THE WIPES, SOME WOULD FALL OFF OR COULD BE MOVED. THIS WAS NOTICED IN BOTH TUBS OF WIPES. THESE CANISTERS WERE SET ASIDE, SO THEY WERE NOT USED AND COULD BE BROUGHT TO MANAGEMENT DURING THE WEEK. TWO DAYS LATER, STAFF WAS GOING TO CLEAN A PATIENT ROOM IN THE ER. WHEN PULLING SOME WIPES OUT OF THE CANISTER THAT WAS IN THE ROOM, THERE WERE THE SAME BROWN/RUSTY LOOKING FLECKS OR SPOTS NOTED AGAIN. ALTHOUGH THIS TIME, THEY WERE NOT ON THE TOP OF THE WIPES, THEY WERE FOUND WITHIN THE WIPES AND IN THE CENTER OF MANY OF THEM. THESE CANISTERS WERE PULLED FROM USE AS WELL. ALL THE CANISTERS HAD THE SAME LOT#, A11900501. CHECKED ALL INVENTORY WITH THIS LOT NUMBER. NO OTHER AFFECTED CANISTERS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537078 SUPER SANI-CLOTH GERMICIDAL DISPOSABLE WIPE PAD, ALCOHOL, DEVICE DISINFECTANT LKB PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. A11900501

    Patients

    Seq Age Sex Outcome Treatment
    1