BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 3237176 · Received July 12, 2013

    Report

    Report Number
    1317749-2013-00220
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 14, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 07/11/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING HAS REQUESTED ADDITIONAL INFORMATION ON 06/20/2013, 07/01/2013, 07/02/2013, 07/08/2013, AND 07/11/2013. 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UNIT WAS FOUND BROKEN ON A (B)(6) PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324848 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA