BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1070534 · Received July 2, 2008

    Report

    Report Number
    3006260740-2008-00031
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 10, 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 A COMPLETE BREAK IN THE FEEDING TUBE IS CONFIRMED, AND SHOULD BE REPORTED AS USER RELATED. THE COMPLETE BREAK IN THE FEEDING TUBE IS THE RESULT OF EXCESSIVE FORCE THAT WAS USED DURING DEVICE REMOVAL. THE BREAK SITE IS LOCATED 0.2 INCHES PROXIMAL TO THE RETENTION DOME. NO DAMAGE TO THE RETENTION DOME WAS OBSERVED. THE DEVICE HAD BEEN IN PLACE FOR APPROXIMATELY 116 DAYS PRIOR TO THE COMPLAINT INCIDENT. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OF DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A CHR 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 INDWELLING PERIOD IS 116 DAYS. THE DOCTOR WAS CONCERNED THAT THE DEVICE MIGHT BE A RECALLED PRODUCT.

    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