BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT

    MDR report key: 17868055 · Received October 4, 2023

    Report

    Report Number
    17868055
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    November 2, 2022
    Report Date
    December 16, 2022
    Manufacturer
    C. R. BARD, INC.
    Product Code
    FCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STAFF REPORTS THAT THREE DIFFERENT DEVICES (USED ON THE SAME PATIENT) FAILED- THE "BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED URETHRAL CATHETER KIT 4A5144" FAILED- EACH TIME IT LEAKED ALL OVER THE PATIENT AND STAFF COULD NOT GET CORRECT DATA FOR OUTPUT ON A PATIENT WHO WAS ADMITTED FOR A UTI (URINARY TRACT INFECTION)- THERE WAS NO HARM TO THE PATIENT OTHER THAN DISTRESS AND INABILITY TO DETERMINE URINARY OUTPUT RESULTS. IT WAS BEING USED AS A SUBSTITUTE PRODUCT AND THE VALUE ANALYSIS TEAM ALONG WITH THE CLABSI/CAUTI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION/CATHETER-ASSOCIATED URINARY TRACT INFECTIONS) COMMITTEE SUBMITTED A COMPLAINT TO THE VALUE ANALYSIS GROUP TO ATTEMPT TO GET A DIFFERENT SUBSTITUTE PRODUCT AS THIS ONE IS NOT SAFE OR EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201023 BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT) FCM C. R. BARD, INC. 4A5144

    Patients

    Seq Age Sex Outcome Treatment
    1 32120 DA Female