BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 2042812 · Received March 30, 2011

    Report

    Report Number
    1317749-2011-00106
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 17, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UVC LEAKS JUST BELOW THE HUB WHERE THE CATHETER IS JOINED. THE UVC WAS PLACED ON (B)(6) 2011 AND REMOVED ON (B)(6) 2011. THE CUSTOMER STATES THAT THE UVC WAS REPLACED WITH ANOTHER UVC AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 019622

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK