BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1203582 · Received October 16, 2008

    Report

    Report Number
    3006260740-2008-00158
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 26, 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

    THIS COMPLAINT IS CONFIRMED AND WILL BE REPORTED AS MANUFACTURING RELATED. RETURNED FOR EVALUATION WAS ONE DISPOSABLE GRASPING SNARE. UPON RECEIPT THE HOPPED 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 NINE OTHER PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    DURING PROCEDURE, THE HOPPED SNARE DETACHED AND FELL INTO THE PT'S STOMACH. THE FALLEN HOOPED SNARE WAS REMOVED WITH GRASPING FORCEPS.

    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