BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCONNECT ENTERAL FEEDING TUBE

    MDR report key: 10401066 · Received August 13, 2020

    Report

    Report Number
    10401066
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 28, 2020
    Manufacturer
    NEOMED, INC.
    Product Code
    BSS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CLOSURE CAP OF THE NG TUBE WILL NOT FIT INTO THE END OF THE NG TUBE. THERE IS A RISK, THAT, PART OR ALL OF THE FEEDING COULD COME OUT OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864561 NEOCONNECT ENTERAL FEEDING TUBE TUBE, NASOGASTRIC BSS NEOMED, INC. PFTL5.0P-NC 20200322

    Patients

    Seq Age Sex Outcome Treatment
    1 120 DA