BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCONNECT ENTERAL EXTENSION SET

    MDR report key: 10754623 · Received October 29, 2020

    Report

    Report Number
    10754623
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    December 23, 2019
    Report Date
    January 7, 2020
    Manufacturer
    NEOMED, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CRACK FOUND IN PATIENT SIDE CONNECTION HUB CREATING A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223235 NEOCONNECT ENTERAL EXTENSION SET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT NEOMED, INC. EXT-60NC 20190829

    Patients

    Seq Age Sex Outcome Treatment
    1 Other