BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1230856 · Received November 6, 2008

    Report

    Report Number
    3006260740-2008-00194
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 4, 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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE INTERNAL DOME WAS TORN FROM THE CATHETER WHEN THE USER ATTEMPTED TRACTION REMOVAL. WHEN HE PLACED A NEW CATHETER THROUGH THE STOMA SITE, IT PENETRATED THE OLD INTERNAL DOME WHICH HAD 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