BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1190539 · Received October 2, 2008

    Report

    Report Number
    3006260740-2008-00142
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 30, 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 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 168 DAYS. THE FOLDING OF THE RETENTION DOME HAD BEEN CONFIRMED ENDOSCOPICALLY BEFORE THE REMOVAL BUT THE DEVICE BROKE UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C. R. BARD INC. (BASD) HURJ1537

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention