BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMED 5.0 FRENCH 60CM PUR

    MDR report key: 7926252 · Received October 1, 2018

    Report

    Report Number
    MW5080272
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    May 8, 2018
    Report Date
    September 18, 2018
    Manufacturer
    NEOMED INCORPORATED
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PREMATURE BABY HAD A 5FR. NEOMED FEEDING TUBE PLACED NASALLY. THE CAP POPS OPEN AFTER FEEDS AND LOSS OF FEEDING IS NOTED. THE FEEDING TUBE CAP WAS TAPED CLOSED AS THE CAP WOULD NOT STAY SHUT. IN ADDITION, WHEN FEEDING TUBE WAS CONNECTED TO ENTERAL FEEDING TUBING (EXTENSION SET), THE EXTENSION SET BECAME LODGED IN THE FEEDING TUBE AND HAD TO BE DISLODGED USING A KELLY CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765092 NEOMED 5.0 FRENCH 60CM PUR FEEDING TUBE FPD NEOMED INCORPORATED FTM5.0P-EO 2017 1227
    765115 NEOMED 5.0 FRENCH 60CM PUR TUBE GASTROINTESTINAL (AND ACCESSORIES) KNT NEOMED INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other