BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELLETHANE

    MDR report key: 856627 · Received May 14, 2007

    Report

    Report Number
    856627
    Event Type
    Malfunction
    Date Received
    May 14, 2007
    Date of Event
    May 9, 2007
    Report Date
    May 10, 2007
    Manufacturer
    VYGON CORP.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    A DOUBLE LUMEN UMBILICAL CATHETER DEVELOPED A LEAK AT THE DISTAL LUMEN LUER LOCK CONNECTION. A CLOSE EXAMINATION REVEALED THAT THE CONNECTOR HAD A CRACK IN IT THAT ALLOWED TPN AND LIPIDS TO LEAK OUT. THIS HAS HAPPENED NUMEROUS TIMES OVER THE LAST TWELVE MONTHS AND THE MANUFACTURER HAS NOT BEEN ABLE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELLETHANE CATHETER, DOUBLE LUMEN UMBILICAL FOS VYGON CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *