BEUDAMED
    FDA Adverse Event Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 1003854 · Received February 26, 2008

    Report

    Report Number
    9611018-2008-00004
    Date Received
    February 26, 2008
    Report Date
    January 28, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER EMAIL IN 2008 4:28 AM: "THIS WAS A VENOUS AND NOT A ARTERIAL CATHETER. ACCORDING TO ULTRASOUND OR X-RAY THE UVC WAS EITHER VENA CAVA INFERIOR OR DUCTUS VENOSUS. THE UMBILICAL VESSEL CATHETER WAS IN BETWEEN 2-5 DAYS BEFORE THEY NOTICED THIS PROBLEM. THE PROBLEM WAS NOTICED MOSTLY AT THE TIME OF EXTRACTION. INFANT WAS RECEIVING TPN, WITHOUT HEPARIN OR RECEIVING HALF PARTIAL, WITHOUT LIPIDS. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED."

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A UMBILICAL VESSEL CATHETER. THE CUSTOMER STATED THAT THERE WAS A FORMATION OF A CLOT AT THE CATHETER TIP. THERE WAS EXTRAVASATION OF PARENTERAL NUTRITION IN LIVER TISSUE SURROUNDING THE VESSEL - PSEUDOCYST CONFIRMED BY ULTRASOUND, CARDIOTOCOGRAPHY. PT INFO: FEMALE, THROMBUS IN INFERIOR VENA CAVA, ULTRASOUND PERFORMED ON DAY 28 (VENTILATED, HYALINE MEMBRANE DISEASE, BRONCHOPULMONARY DYSPLASIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS TYCO HEALTHCARE/KENDALL 8888160333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA