BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBES, GASTROINTESTINAL (AND ACCESSORIES)

    MDR report key: 9510278 · Received December 23, 2019

    Report

    Report Number
    9510278
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 18, 2019
    Report Date
    December 19, 2019
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    6 FR NASO-GASTRIC TUBE (NGT) PLACED. UPON ATTEMPTED REMOVAL OF WIRE, PINK CAP BROKE OFF. WIRE WAS STILL ABLE TO BE REMOVED, HOWEVER, UPON ATTEMPTING ASPIRATE, THE NURSE NOTED THAT THERE WAS A HOLE AT THE TOP OF NGT (RIGHT UNDER THE CAPS). NGT REMOVED AND AN ALTERNATIVE TUBE PLACED WITHOUT INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304972 TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1