BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 3120502 · Received May 9, 2013

    Report

    Report Number
    1317749-2013-00147
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 9, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING HAS REQUESTED ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UVC WAS INSTALLED ON (B)(6) 2013 AT 6:00PM. ON (B)(6) 2013 THEY NOTICED A LEAK AT THE CONNECTION SITE OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203831 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 030306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK