BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5F POLYURETHANE UMBILICAL CATHETER

    MDR report key: 2091581 · Received April 27, 2011

    Report

    Report Number
    2245270-2011-00020
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 27, 2011
    Manufacturer
    VYGON SA
    Product Code
    FOS
    PMA / PMN Number
    K921352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MADE BY VYGON SA IN FRANCE. THE SAMPLE WAS SENT OVERSEAS TO VYGON (B)(4) ON (B)(4), 2011. RESULTS OF THE INVESTIGATION ARE NOT YET COMPLETE, BUT WILL BE SUBMITTED TO FDA IN A FOLLOW UP MDR WITHIN A MONTH OF COMPLETION.

    Description of Event or Problem · 1

    DUAL LUMEN UMBILICAL CATHETER WITH A CRACKED GREEN HUB. THE CATHETER HAD BEEN IN PLACE FOR 4 DAYS AND HAD LIPIDS INFUSING THROUGH THE DISTAL GREEN HUB LUMEN USING A PUMP. THE CATHETER WAS REMOVED WITHOUT INCIDENT. NO PT HARM OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5F POLYURETHANE UMBILICAL CATHETER UMBILICAL CATHETER FOS VYGON SA 1274.17 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1