BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1230858 · Received October 28, 2008

    Report

    Report Number
    3006260740-2008-00179
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 2, 2008
    Manufacturer
    C. R. BARD INC. (BARD)
    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

    THIS COMPLAINT IS CONFIRMED AND WILL BE REPORTED AS MFG RELATED. RETURNED FOR EVAL WAS ONE DISPOSABLE GRASPING SNARE. UPON RECEIPT, THE HOOPED SNARE HAD DETACHED FROM ITS METAL LOCKING CRIMP. GROSS AND MICROSCOPIC EXAMINATIONS REVEAL AN IMPROPER CRIMP. THE DIMENSIONAL MEASUREMENTS FOR THE LOCKING METAL CRIMP ARE NOT WITHIN DIMENSIONAL SPECIFICATIONS. NO DAMAGE TO THE GRASPING SNARE HOOP WAS OBSERVED. A CHR OF LOT #HUSA0275 SHOWED TEN OTHER PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    WHEN GRASPING THE INSERTION WIRE WITH THE SNARE, THE HOOPED SNARE DETACHED AND FELL INTO THE PT'S STOMACH. THE FALLEN HOOPED SNARE WAS REMOVED ENDOSCOPICALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention