BEUDAMED
    FDA Adverse Event Other Summary report: N

    5FR DUAL-LUMEN UVC CATH

    MDR report key: 1023779 · Received March 20, 2008

    Report

    Report Number
    1317749-2008-00031
    Event Type
    Other
    Date Received
    March 20, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 27, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER SALES REP. "THE TPN HAD TO BE DRAWN FROM THE PATIENTS BELLY. THE PATIENT IS DOING FINE. 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 ON 2/27/2008 THAT A CUSTOMER HAD A PROBLEM WITH A UMBILICAL VESSEL CATHETER. CUSTOMER STATED: "ONCE THE UVC HAD BEEN PLACED WE FOUND THAT IT HAD INFILTRATED THE BELLY OF THE PATIENT. WE THEN REMOVED THE UVC AND WITHDREW THE TPN FROM THE BELLY OF THE PATIENT. NURSE SAID THE UVC LOOKS NORMAL AND NOTHING SEEMED DIFFERENT WITH THE PT AS COMPARED TO OTHERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5FR DUAL-LUMEN UVC CATH NONE FOS TYCO HEALTHCARE/KENDALL 8888160556 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK