BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARG SALEM SUMP TB W/ARV 16 FR STRL

    MDR report key: 2364899 · Received December 5, 2011

    Report

    Report Number
    9612030-2011-00020
    Event Type
    Death
    Date Received
    December 5, 2011
    Date of Event
    November 10, 2011
    Report Date
    December 2, 2011
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 12/2/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 12/2/2011 THAT A CUSTOMER HAD AN ISSUE WITH A GASTRO INTESTINAL TUBE. THE CUSTOMER REPORTS THAT AFTER THE TUBE WAS INSERTED, THEY LISTENED FOR AIR AND HEARD NONE. THE TUBE WAS PULLED AND THE END WAS NOTED TO BE JAGGED. IT WAS THEN DISCOVERED THAT THE TIP OF THE TUBE HAD BROKEN OFF, ROUGHLY THREE INCHES BELOW THE 10 MARK, AND REMAINED INSIDE THE PT. THE TIP OF THE TUBE WAS UNABLE TO BE RETRIEVED FROM THE PT, AS THE PT EXPIRED THAT SAME DAY TO UNRELATED HEALTH CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARG SALEM SUMP TB W/ARV 16 FR STRL GASTRO INTESTINAL TUBE KNT COVIDIEN 8888266130 421506464

    Patients

    Seq Age Sex Outcome Treatment
    1 Death