BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY LOW PROFILE (TRANSGASTRIC JEJUNAL FEEDING TUBE)

    MDR report key: 6345046 · Received February 21, 2017

    Report

    Report Number
    6345046
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    January 28, 2017
    Report Date
    February 10, 2017
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A NASOGASTRIC JEJUNAL TUBE (NGJ) WAS INSERTED IN THE PATIENT IN INTERVENTIONAL RADIOLOGY. THE PATIENT WAS ADMITTED TO THIS FACILITY APPROXIMATELY 10 DAYS AFTER NGJ INSERTION WITH FEEDING INTOLERANCE AND FREE ABDOMINAL AIR NOTED ON THE X-RAY. THE PATIENT SUBSEQUENTLY UNDERWENT ABDOMINAL EXPLORATORY LAPAROTOMY AND PRIMARY REPAIR OF THE JEJUNAL PERFORATION LOCATED AT THE TIP OF THE NASOGASTRIC JEJUNAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127903 MIC-KEY LOW PROFILE (TRANSGASTRIC JEJUNAL FEEDING TUBE) TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT HALYARD HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other| R