BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 3220679 · Received June 25, 2013

    Report

    Report Number
    1317749-2013-00189
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    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 WHILE TAKING BLOOD FROM THE CATHETER A LEAK WAS FOUND BELOW THE MOLDED STRAIN RELIEF. CHLORIDE HEXIDINE WAS USED TO CLEAN THE AREA AND IT WAS DRIED COMPLETELY PRIOR TO INSERTION. THE UVC WAS NOT DIFFICULT TO SECURE AND WAS SECURED BY SUTURE AROUND THE UMBILICAL CORD AND STRIPS ATTACHED TO THE CATHETER. THE UVC WAS INSERTED ON (B)(6) 2013 INTO THE UMBILICAL ARTERY. IT WAS REMOVED ON (B)(6) 2013 AND WAS NOT REPLACED. THE PT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288576 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK