BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYGON

    MDR report key: 374311 · Received January 25, 2002

    Report

    Report Number
    MW1023925
    Event Type
    Malfunction
    Date Received
    January 25, 2002
    Date of Event
    January 9, 2002
    Report Date
    January 25, 2002
    Manufacturer
    VYGON CORP
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UMBILICAL ARTERY CATHETER INSERTED IN PT AT APPROX 02:00. REMOVED THE SAME DATE AT APPROX 14:25. FIVE DAYS LATER, X-RAY INTERPRETATION REVEALED APPROX 1 CM RETAINED CATHETER TIP. CATHETER TIP IN PORTION OF UMBILICAL ARTERY THAT WILL NATURALLY FORM INTO LIGAMENTOUS REMNANT, THEREFORE LOW RISK OF EMBOLISM. POTENTIAL RISK FOR INFECTION, THEREFORE TIP WILL BE REMOVED UNDER LOCAL ANESTHETIC PRIOR TO PT'S DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYGON UMBILICAL ARTERY CATHETER FOS VYGON CORP 1270.03 (SIZE 3.5) *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other