BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE SALEM SUMP TUBE

    MDR report key: 6379835 · Received March 6, 2017

    Report

    Report Number
    6379835
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    January 29, 2017
    Report Date
    February 22, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COUPLE ISSUES WERE REPORTED ABOUT NASOGASTRIC TUBES (NGT): NGT PLACED AND THE TUBE DEVELOPED WHAT APPEARED TO BE A HOLE IN IT, WAS MAKING A GURGLING SOUND. WHEN I FLUSHED IT THE PATIENT REPORTED BEING ABLE TO FEEL THE FLUID IN HER THROAT. DOCTOR WAS NOTIFIED. HE'S GOING TO EXAMINE IT IN THE AM AND DETERMINE WHAT NEEDS TO HAPPEN. THIS PARTICULAR EQUIPMENT FAILURE IS A PATIENT SAFETY ISSUE LED TO INCREASED PAIN, NAUSEA, DISTENDED ABDOMEN, ETC. PATIENT WAS CONNECTED TO NGT FOR A COUPLE OF DAYS AND HAD HIM AT CONTINUOUS SUCTION, NOTICED IT WAS NOT WORKING PROPERLY, TRIED TO SEE IF IT WAS CLOGGED AND TRIED SOME METHODS TO GET IT WORKING. WE FOUND A LARGE HOLE IN THE NGT WHERE THE ANTI-REFLUX VALVE MEETS WITH THE OTHER PART OF THE TUBE. VERY LARGE HOLE AND UNABLE TO GET IT TO SEAL. THIS MAY REQUIRE THE TUBE BEING REPLACED AGAIN IF THE PATIENT IS UNABLE TO GET ALONG WITHOUT IT. ANTI-REFLUX VALVE CAP BROKE OFF IN THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164969 ARGYLE SALEM SUMP TUBE TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1