BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1120503 · Received August 14, 2008

    Report

    Report Number
    3006260740-2008-00075
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 24, 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 COMPLAINT OF THE RETENTION DOME DETACHING DURING TRACTION 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 REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME. THE DOME WAS SEPARATED FROM THE ADHESION AREA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention