BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM

    MDR report key: 7342636 · Received March 15, 2018

    Report

    Report Number
    7342636
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 11, 2018
    Report Date
    February 27, 2018
    Manufacturer
    C.R. BARD INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN DIGNICARE FCD IN PLACE. ON THIS PARTICULAR PATIENT, ON THIS PARTICULAR DAY, THE INJECTION PORT SPONTANEOUSLY FALLS OFF AND THE FCD NEEDS TO BE REPLACED. THIS HAPPED X3 KNOWN TIMES THIS WEEKEND. HAPPENS REGULARLY, NURSES JUST REPLACE IT AND DISCARD IT. THEN NURSE HAD THE PACKAGING FROM THE REPLACEMENT THAT ALSO HAD A PORT FALL OFF AND IT IS LOT NGBZ3294. GENERALLY, ONE OF THE PORTS IS FOUND IN THE BED OR THE FLOOR. IT SEEMS TO BE HAPPENING MORE FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183727 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT C.R. BARD INC. SMS002 NGBZ3294

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR