BEUDAMED
    FDA Adverse Event Death Summary report: N

    HALYARD

    MDR report key: 9646707 · Received January 30, 2020

    Report

    Report Number
    9646707
    Event Type
    Death
    Date Received
    January 30, 2020
    Date of Event
    December 24, 2019
    Report Date
    January 14, 2020
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ELDERLY FEMALE PATIENT WITH UNRESECTABLE ESOPHAGEAL CANCER AND DYSPHAGIA UNDERWENT ELECTIVE FEEDING JEJUNOSTOMY TUBE REPLACEMENT. AFTERWARDS, SHE DEVELOPED SBO INITIALLY THOUGHT TO BE RELATED TO A TWIST IN THE SMALL BOWEL, THIS WAS SURGICALLY CORRECTED. AFTER THAT, HER SBO FAILED TO RESOLVE, AND REPEAT IMAGING SHOWED THAT THE 3ML BALLOON OF THE J-TUBE TO BE THE POINT OF OBSTRUCTION. THE BALLOON WAS DEFLATED, BUT BY THAT TIME SHE HAD ALREADY ASPIRATED, DEVELOPED PNEUMONIA, THEN SEPSIS, AND DEATH. DOCTOR'S RECOMMENDATION IS TO FIND A DIFFERENT J-TUBE THAT DOES NOT HAVE A BALLOON. CURRENTLY THE MANUFACTURER DOES NOT OFFER THE FEEDING J-TUBE WITHOUT THE BALLOON. IT WAS THOUGHT THAT THE BALLOON WAS NOT LARGE ENOUGH TO CAUSE A SMALL BOWEL OBSTRUCTION,BUT THIS IS A SENTINEL CASE THAT PROVES THE BALLOON IS LARGE ENOUGH TO CAUSE OBSTRUCTION. MANUFACTURER RESPONSE FOR FEEDING TUBE JEJUNOSTOMY, HALYARD (PER SITE REPORTER). WILL NOTIFY MANUFACTURER ONCE THIS REPORT IS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111312 HALYARD TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 44566

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA Death