BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYGON

    MDR report key: 877075 · Received May 24, 2007

    Report

    Report Number
    877075
    Event Type
    Injury
    Date Received
    May 24, 2007
    Date of Event
    May 20, 2007
    Report Date
    May 24, 2007
    Manufacturer
    VYGON CORP
    Product Code
    FOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    AN UMBILICAL CATHETER DEVELOPED A LEAK AT THE LUER LOCK CONNECTION. A CLOSE EXAMINATION REVEALED THAT THE CONNECTOR HAD A CRACK IN IT THAT ALLOWED TPN, LIPIDS, FENTANYL AS WELL AS BLOOD TO LEAK OUT. FLUID LOSS AS WELL AS INADEQUATE MEDICATION CONTRIBUTED TO A SITUATION WHERE THE NEONATE WAS TEMPORARILY VERY UNSTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention