BEUDAMED
    FDA Adverse Event Summary report: N

    1.9F ARGYLE SINGLE LUMEN PICC

    MDR report key: 709995 · Received November 28, 2005

    Report

    Report Number
    1317749-2005-00052
    Date Received
    November 28, 2005
    Date of Event
    November 21, 2005
    Report Date
    November 28, 2005
    Manufacturer
    TYCO/KENDALL HEALTHCARE
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO/KENDALL HEALTHCARE ON 11/21/2005 THAT A CUSTOMER HAD A PROBLEM WITH THE KENDALL SINGLE LUMEN PICC CATHETER. THE CUSTOMER STATES "THE SINGLE LUMEN PICC LEAKED BELOW THE STABILIZING WING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9F ARGYLE SINGLE LUMEN PICC KENDALL SINGLE LUMEN CATHETER LJS TYCO/KENDALL HEALTHCARE 43303 164049

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN