BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1277666 · Received November 21, 2008

    Report

    Report Number
    3006260740-2008-00219
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 6, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K033562
    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 AT THIS TIME FOR EVALUATION. A CHR REVIEW SHOWED SEVENTEEN OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT. REF. 187519, 188387, 190699, 191631, 191638, 191645, 192115, 192149, 192640, 192665, 195079, 196501, 196516, 19849, 198622, 199010 & 199012.

    Description of Event or Problem · 1

    WHEN THE USER GRASPED THE INSERTION WIRE WITH THE SNARE, THE HOOPED SNARE DETACHED AND FELL INTO THE PATIENT'S STOMACH. THE FALLEN HOOPED SNARE WAS REMOVED WITH ANOTHER SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C. R. BARD INC. (BASD) HUSA0275

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention