BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE LUMEN UMBILICAL CATHETER

    MDR report key: 3837580 · Received March 3, 2014

    Report

    Report Number
    2245270-2014-00012
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 28, 2014
    Manufacturer
    VYGON SA
    Product Code
    FOS
    PMA / PMN Number
    K981630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE MALFUNCTIONING DEVICE WAS NOT RETURNED TO VYGON U.S, THE COMPLAINT HAS BEEN FORWARDED TO VYGON SA (THE MANUFACTURER) FOR COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA VIA A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    A 5FR DOUBLE LUMEN UMBILICAL CATHETER PLACED ON (B)(6) 2014 WAS FOUND LEAKING FROM THE "STUMP" ON (B)(6) 2014 AND REMOVED. THE LINE WAS REPLACED, AND THE PATIENT SHOWS NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127557 DOUBLE LUMEN UMBILICAL CATHETER CATHETER, UMBILICAL ARTERY FOS VYGON SA 1274.14 270312E1

    Patients

    Seq Age Sex Outcome Treatment
    1