BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRISAFE 2 PUR FEEDING TUBE

    MDR report key: 3873703 · Received March 6, 2014

    Report

    Report Number
    2245270-2014-00013
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 30, 2014
    Report Date
    March 5, 2014
    Manufacturer
    VYGON SA
    Product Code
    FPD
    PMA / PMN Number
    K060944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO ADDITIONAL OCCURENCES OF THIS PRODUCT PROBLEM WERE OBSERVED BY THE CUSTOMER. ADDITIONAL INFORMATION ON THESE OCCURRENCES CAN BE FOUND IN THE FOLLOW MDR'S: 2245270-2014-00014 AND 00015. A MALFUNCTIONING DEVICE WAS RETURNED TO VYGON US AND WAS FORWARDED TO VYGON (B)(4) (THE MANUFACTURER) FOR DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE FORWARDED TO FDA UPON ITS COMPLETION VIA A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    FEEDING TUBE MARKINGS ARE RUBBING OFF AROUND AREAS THAT IS TOUCHING BABY. FEEDING TUBE NEEDED TO BE REPLACED BECAUSE THERE WAS NO CLEAR INDICATION IF TUBE WAS MIGRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134403 NUTRISAFE 2 PUR FEEDING TUBE ENTERAL FEEDING TUBE FPD VYGON SA 1363.052 201212FE

    Patients

    Seq Age Sex Outcome Treatment
    1