BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1030207 · Received April 14, 2008

    Report

    Report Number
    2523003-2008-00031
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 18, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE, AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION DOME REMOVAL. THE INCIDENT OCCURRED 161 DAYS AFTER PLACEMENT. THE DOME SECTION DROPPED INTO THE PATIENT'S STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C.R. BARD, INC. (BASD) 43LQA206

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention