BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS TRANSGASTRIC JEJUNAL FEEDING TUBE

    MDR report key: 1020752 · Received March 10, 2008

    Report

    Report Number
    1320599-2008-00003
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    MOSS TUBES, INC.
    Product Code
    KNT
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MOSS TUBES, INC. HAS CALLED REP OF THE FACILITY TO OBTAIN THE TUBE IN QUESTION. WE WERE TOLD THAT THE TUBE WILL BE SENT TO US. THUS FAR IT HAS NOT ARRIVED. WHEN IT DOES IT WILL BE SENT TO OUR MFR FOR AN EVAL. THUS FAR WE HAVE NO ADD'L INFO.

    Description of Event or Problem · 1

    FACILITY SENT A MEDWATCH TO THE FDA AND WE REC'D THIS REPORT ON MARCH 05, 2008 FROM THE FDA. ON 3/5/08 THE REPORT STATES THAT "THE FAMILY OF THE PT OBSERVED AN RN INJECTING INTO THE BALLOON PORT." "WHEN THE TUBE WAS INSPECTED IT WAS FOUND TO HAVE A BURST BALLOON. THIS MAY HAVE LED TO TUBE MALPOSTION AND ASSOCIATED PROBLEMS." DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? "NO". WHAT WAS THE ORIGINAL INTENDED PROCEDURE? "FEEDING THROUGH, GIVING MEDS THROUGH, AND FLUSHING FEEDING TUBE." THIS REPORT WAS SENT TO US BY MAIL AND NO PHONE CALL OF OTHER INFO WAS PROVIDED TO MOSS TUBES, INC. WE HAVE SENT A LETTER REQUESTING THE TUBE IN QUESTION AND A WRITTEN DESCRIPTION OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSS TRANSGASTRIC JEJUNAL FEEDING TUBE TRANSGASTRIC JEJUNAL FEEDING TUBE KNT MOSS TUBES, INC. 2-20125 7379

    Patients

    Seq Age Sex Outcome Treatment
    1 *