BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYGON

    MDR report key: 21984663 · Received May 8, 2025

    Report

    Report Number
    21984663
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 19, 2025
    Report Date
    May 1, 2025
    Manufacturer
    VYGON S A
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NNP [NEONATAL NURSE PRACTITIONER] WAS PLACING AN UMBILICAL VENOUS CATHETER. THE NUMBERS ON THE CATHETER WORE OFF AS SOON AS SHE TOUCHED THEM. IT WAS DIFFICULT FOR HER TO KNOW HOW DEEP THE LINE WAS. WAS NOT REMOVED FROM SERVICE AS CATHETER WAS ALREADY INSERTED INTO UMBILICUS AND CATHETER WAS FUNCTIONAL. WAS MORE BENEFICIAL TO BABY TO LEAVE IN RATHER THAN REPLACE WITH A NEW CATHETER. DEPTH WAS ESTIMATED. INITIALLY HAD ISSUE FLUSHING AND DRAWING BACK ON CATHETER. LINE WAS PULLED BACK TO LOW LYING AND THEN REMOVED WHEN PIV [PERIPHERAL INTRAVASCULAR LINE] WAS PLACED. (UNFORTUNATELY, PACKAGING AND DEVICE WERE BOTH DISCARDED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035890 VYGON CATHETER, UMBILICAL ARTERY FOS VYGON S A 1274.14 OTHERS ON SHELF ARE 031024EI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown