BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT NEOCONNECT

    MDR report key: 10211404 · Received June 30, 2020

    Report

    Report Number
    10211404
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    May 6, 2020
    Report Date
    May 26, 2020
    Manufacturer
    NEOMED, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE LEAKING FROM CONNECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674404 ENFIT NEOCONNECT TUBE, FEEDING FPD NEOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1