BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1231112 · Received November 11, 2008

    Report

    Report Number
    3006260740-2008-00202
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 21, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE RETENTION DOME DETACHING DURING REMOVAL (SEPARATION OF THE DOME AND FEEDING TUBE) IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS SHOW THE RETENTION DOME HAS COMPLETELY SEPARATED FROM THE OD OF THE FEEDING TUBE. A CHR OF LOT # HURJ1535 SHOWED NO OTHER PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 182 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C. R. BARD INC. (BASD) HURJ1535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention