BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1230019 · Received November 12, 2008

    Report

    Report Number
    3006260740-2008-00201
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 21, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K033562
    Adverse Event
    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 SUPPLIER RELATED. RETURNED FOR EVAL ARE THREE DISPOSABLE GRASPING SNARES. UPON RECEIPT OF THREE HOOP, SNARES HAVE DETACHED FROM THEIR METAL LOCKING CRIMPS. GROSS AND MICROSCOPIC EXAMINATIONS OF ALL THREE SNARE HOOPS REVEAL AN IMPROPER CRIMP. THE DIMENSIONAL MEASUREMENTS OF ALL THREE LOCKING METAL CRIMPS SHOW THEY ARE NOT WITHIN DIMENSIONAL SPECS. NO DAMAGE TO ALL THREE GRASPING SNARE HOOPS WAS OBSERVED. A CHR OF LOT #HUSA0275 SHOWED THIRTEEN OTHER PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    WHEN THE USER WAS PULLING THE SNARE OUT OF THE PT'S MOUTH, THE HOOP SNARE DETACHED AND FELL INTO THE PT'S STOMACH. THE FALLEN HOOP SNARE WAS REMOVED LATER. THEN, THE USER USED A NEW KIT IN STOCK, AND THE HOOP SNARE DETACHED AGAIN. THE USER OPENED ANOTHER KIT WITH THE SAME LOT TO CHECK, AND AS HE PULLED THE HOOP SNARE, IT BROKE.

    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