BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1101024 · Received August 1, 2008

    Report

    Report Number
    3006260740-2008-00056
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 8, 2008
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Adverse Event
    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 IS CONFIRMED. IT SHOULD BE NOTED THAT ONLY THE SEPARATED RETENTION DOME WAS RETURNED FOR EVALUATION. THE DULL AND ROUNDED VENEER IDENTIFIED AT THE DOME SITE ARE TRAITS THAT ARE INDICATIVE OF EXCESSIVE FORCE THAT WAS APPLIED DURING THE REMOVAL OF THIS DEVICE. AT THIS TIME, THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THE SECTION THAT CONTAINS THE FEEDING TUBE AND DUAL FEEDING ADAPTER WERE NOT RETURNED FOR EVALUATION. A CHR IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFORMATION HAS BEEN PROVIDED BY THE COMPLAINT.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 196 DAYS. THE DOME PORTION WAS REMOVED ENDOSCOPICALLY.

    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