BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHWERWOOD

    MDR report key: 261732 · Received February 9, 2000

    Report

    Report Number
    MW1018097
    Event Type
    Injury
    Date Received
    February 9, 2000
    Report Date
    February 8, 2000
    Manufacturer
    THE KENDALL CO. LP
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MONTH AGO FACILITY HAD PROBLEM WITH A SHERWOOD FEEDING TUBE. BECAUSE OF THEIR PREVIOUS BAD EXPERIENCE, ONE OF THEIR DRS CHECKED THE TUBE BEFORE PLACING IT IN A PT. AFTER JUST GENTLY PULLING THE TUBE, THE WEIGHT PART OF THE TUBE CAME OFF. THE SIZE OF THE FEEDING TUBE WAS 4.0MM X 110CM AND THE LOT NUMBER C98G291E. THIS IS THE SAME LOT AS THE PREVIOUS PROBLEMATIC TUBE. THIS IS A MAJOR DEFECT WITH THIS PRODUCT AND RPTR WOULD APPRECIATE IF "FDA WOULD CONTACT THE MFR, FDA OR OTHER APPROPRIATE BODIES. FACILITY WOULD ALSO APPRECIATE YOUR TAKING THIS LOT OFF THE SHELVES AND SUBSTITUTING THEM FOR ANOTHER LOT IN OUR HOSP AND OTHERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHWERWOOD FEEDING TUBE KNT THE KENDALL CO. LP * C98G291E

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening