BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCONNECT ENTERAL FEEDING TUBE

    MDR report key: 10545969 · Received September 17, 2020

    Report

    Report Number
    10545969
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 15, 2020
    Manufacturer
    NEOMED, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN RETURNING NASOPHARYNGEAL TUBE RESIDUAL, NURSE NOTICED A SMALL BUBBLE OF RESIDUAL LEAKING FROM SMALL PUNCTURE HOLE ON SIDE OF SIL ENTERAL FEEDING TUBE WITH ENFIT CONNECTOR, ORANGE, 5FR X 60CM. NURSE REMOVED NASOPHARYNGEAL TUBE, AND PLACED ANOTHER NASOPHARYNGEAL TUBE. MANUFACTURER RESPONSE FOR SILICONE FEEDING TUBE WITH ENFIT CONNECTOR, ENFIT (PER SITE REPORTER). NOTHING YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012408 NEOCONNECT ENTERAL FEEDING TUBE TUBE, FEEDING FPD NEOMED, INC. FTM5.0S-NC

    Patients

    Seq Age Sex Outcome Treatment
    1