BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1230849 · Received November 6, 2008

    Report

    Report Number
    3006260740-2008-00192
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 14, 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 A BREAK IN THE RETENTION DOME 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 MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS UNK. THE DOME PORTION FELL INTO THE PT'S STOMACH AND REMAINED THERE.

    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