BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR DUAL-LUMEN UVC CATH

    MDR report key: 1894147 · Received November 4, 2010

    Report

    Report Number
    1317749-2010-00300
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 13, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THE UVC WAS LEAKING EXTERNALLY AND HAD TO BE REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5FR DUAL-LUMEN UVC CATH UVC FOS COVIDIEN 8888160531 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK