BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1203568 · Received October 16, 2008

    Report

    Report Number
    3006260740-2008-00156
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 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 FEEDING TUBE DETACHING FROM THE LOCKING CLIP IS CONFIRMED. THE NOTES IN THIS FILE INDICATE, "THE RETENTION DOME FELL INTO THE PT'S STOMACH". THE GENIE TRICUSPID PLUG WAS RETURNED LOCKED TO ITS LOCKING RETENTION CLIP. THE DETACHED PONSKY FEEDING TUBE WAS NOT RETURNED FOR EVAL. THE DEVICE HAD BEEN IN PLACE FOR 17 DAYS PRIOR TO THE COMPLAINT INCIDENT. AT THIS TIME, THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A CHR IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINT.

    Description of Event or Problem · 1

    THE RETENTION DOME FELL INTO THE PT'S STOMACH. THE INDWELLING PERIOD WAS 17 DAYS. THE DEVICE WAS PLACED IN THE PT IN 2008. LOW-PROFILE CONVERSION WAS PERFORMED IN THE SAME MONTH. THE TUBE WAS CUT HORIZONTALLY. THE RETENTION DOME WAS FOUND TO HAVE FALLEN INTO THE PT'S STOMACH ON THE EVENING OF THE FOLLWOING MONTH, IT WAS UNK WHETHER OR NOT THE PT PULLED THE DEVICE OUT. SINCE THE INCIDENT HAPPENED IN THE EVENING, THE DOME COULD NOT BE REMOVED ENDOSCOPICALLY. FOUR DAYS LATER, THE DOME PORTION HAD NOT BEEN REMOVED.

    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