BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

    MDR report key: 19190980 · Received April 26, 2024

    Report

    Report Number
    19190980
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 11, 2024
    Manufacturer
    C. R. BARD, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FECAL MANAGEMENT DEVICE PLACED. FOLLOWING DAY, RN (REGISTERED NURSE) NOTICED THAT THE DEVICE STOPPED DRAINING. ONCE THE BAG WAS CHANGED FROM THE ONE INCLUDED IN THE INITIAL KIT TO A REPLACEMENT BAG, A LARGE AMOUNT OF STOOL WOULD DRAIN. THIS HAPPED A FEW MORE TIMES AFTER THE INITIAL BAG CHANGED. MANUFACTURER RESPONSE FOR STOOL MANAGEMENT SYSTEM, DIGNISHIELD STOOL MANAGEMENT SYSTEM (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO BD CUSTOMER SERVICE. CONTAMINATED EQUIPMENT WAS DISCARDED DUE TO INFECTION CONTROL PRACTICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123293 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT C. R. BARD, INC. SMS002 NGHY1311 OR NGHY0549

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female