BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5F POLYURETHANE UMBILICAL CATHETER

    MDR report key: 1906963 · Received November 5, 2010

    Report

    Report Number
    2245270-2010-00016
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 5, 2010
    Manufacturer
    VYGON SA
    Product Code
    FOS
    PMA / PMN Number
    K921352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED DEVICE WAS NOT SENT BACK. THE CLINICIANS WERE CONTACTED SEVERAL TIMES BY VYGON'S SALES REP TO OBTAIN ADDITIONAL INFO ON THE DETAILS SURROUNDING THE EVENT, BUT CLINICIAN WOULD NOT PROVIDE DETAILS. THE RISK MANAGER WAS CONTACTED BY VYGON REGULATORY AFFAIRS VIA E-MAIL AND TELEPHONE ON (B)(4), 2010, IN ORDER TO OBTAIN ADDITIONAL INFO REGARDING THE EVENT. A PHONE CALL WAS RECEIVED FROM THE RISK MANAGER ON (B)(4) 2010, TO REGULATORY AFFAIRS, AND WAS TOLD THAT THE BABY REQUIRED A TRANSFUSION. WHEN INQUIRING ABOUT WHETHER THE DEVICE MALFUNCTIONED IN ANY MANNER, NO INFO WAS PROVIDED. THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION. RESULTS WILL BE FILED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    AN UMBILICAL CATHETER WAS PLACED IN NEONATE WITH INFUSION BEING CARRIED OUT BY A PUMP AND AFTER APPROXIMATELY 19 HOURS, THE CATHETER EXPERIENCED AN INTERRUPTION. THE BABY EXPERIENCED BLOOD LOSS AND REQUIRED A TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5F POLYURETHANE UMBILICAL CATHETER UMBILICAL CATHETER FOS VYGON SA 1270.03 200703EL OR 100703E

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening| R