BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYGON DL 1.9 FR PICC

    MDR report key: 21273012 · Received January 30, 2025

    Report

    Report Number
    21273012
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    December 6, 2024
    Report Date
    December 18, 2024
    Manufacturer
    VYGON S A
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN THE RN WENT IN TO DO AN ASSESSMENT, FOUND THE BED WET AND PICC LEAKING WITH A HOLE IN THE CATHETER. PICC HAD TO BE REMOVED. NO DEVIATIONS NOTED IN CARE OF LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692030 VYGON DL 1.9 FR PICC VYGON DOUBLE LUMEN PICC LJS VYGON S A 231417

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male