BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 2903968 · Received November 30, 2012

    Report

    Report Number
    1317749-2012-00307
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 27, 2012
    Report Date
    November 2, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UVC LINE BROKE FOUR CM FROM THE DISTAL TIP DURING REMOVAL. THE AREA WAS CLEANED WITH DEXADIN AND DRIED COMPLETELY PRIOR TO INSERTION. THE CATHETER WAS NOT DIFFICULT TO HANDLE DURING INSERTION. IT WAS INSERTED IN THE UMBILICAL CORD AND THE LINE WAS FLUSHED ON A REGULAR BASIS. THE CUSTOMER FURTHER REPORTS THAT THE UVC WAS REMOVED ON (B)(6) 2012 AND WAS NOT REPLACED. THE PT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK