BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 2851402 · Received October 30, 2012

    Report

    Report Number
    1317749-2012-00240
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Report Date
    October 2, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. 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) 2012, THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTED THAT THE CATHETER LEAKED IN THE PROXIMAL AREA, THERE WAS A CONSTANT DRIP. NO INJURY TO THE PATIENT WAS REPORTED, THE UVC WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5FR P.U.R. UMBIL CATH X10 FOS COVIDIEN 8888160333 12702

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN