BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHRANE UBM CATH

    MDR report key: 3060573 · Received March 27, 2013

    Report

    Report Number
    1317749-2013-00107
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT UPON OPENING, THERE ARE VISIBLE KINKS ALONG THE CATHETER WHICH RENDER THE CATHETER COMPLETELY NON-REUSABLE. ON (B)(6) 2013, THE UVC WAS REC'D IN AN OPENED PACKAGE IN (B)(4). PER A VISUAL INSPECTION OF THE CATHETER, IT WAS OBSERVED TO BE STRETCHED, LEAVING THE APPEARANCE OF STRUCTURAL DEFORMITY AND THEREFORE HAS THE POTENTIAL FOR LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124962 3.5FR URETHRANE UBM CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 229604X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK