BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCONNECT ENTERAL EXTENSION SET

    MDR report key: 10501828 · Received September 8, 2020

    Report

    Report Number
    10501828
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 21, 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

    BABY WAS RECEIVING FEEDS VIA EXTENSION TUBE AND THE DEVICE WAS FOUND LEAKING. NURSE DISCOVERED THAT THE LEAK WAS CAUSED BY A CRACK AT THE CONNECTOR PART OF THE TUBING. MANUFACTURER RESPONSE FOR BIFURCATED ENTERAL EXTENSION SET, NEOCONNECT (PER SITE REPORTER): THEY HAVE REFERRED CASE TO THEIR QUALITY DEPARTMENT FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966200 NEOCONNECT ENTERAL EXTENSION SET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT NEOMED, INC. EXT-60YNC 20190619

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA