BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 6053487 · Received October 25, 2016

    Report

    Report Number
    6053487
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 17, 2016
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    KGC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A GASTRIC TUBE PLACEMENT THE MD ADVANCED THE SHEATH; IT KINKED AND BENT. WHEN THE INTERNAL PORTION OF THE SHEATH WAS REMOVED, THE RADIOLOGIC TECHNOLOGIST NOTED A SMALL RING-LIKE PORTION THAT LOOKED LIKE THE SHEATH THAT HAD BROKEN. THE MD WAS REVIEWING THE POST-PROCEDURE X-RAY AND NOTED THAT THE SHEATH WAS RETAINED INSIDE THE PATIENT'S STOMACH. THE PATIENT UNDERWENT AN ENDOSCOPIC RETRIEVAL TO REMOVE THIS DILATOR SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705308 HALYARD TUBE, GASTRO-ENTEROSTOMY KGC HALYARD HEALTH, INC. 98433 AA6186R10

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NO| NO OTHER THERAPIES