BEUDAMED
    FDA Adverse Event Summary report: N

    DUAL LUMEN INSERTION TRAY

    MDR report key: 756667 · Received November 15, 2005

    Report

    Report Number
    1314412-2005-00020
    Date Received
    November 15, 2005
    Date of Event
    January 1, 2005
    Report Date
    November 15, 2005
    Manufacturer
    TYCO/KENDALL HEALTHCARE
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/15/2005

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO/KENDALL HEALTHCARE ON 10/24/2005 THAT A CUSTOMER HAD A PROBLEM WITH THE KENDALL DUAL LUMEN PICC CATHETER. THE CUSTOMER STATES "THE CATHETER DEVELOPED A HOLE DIRECTLY BELOW THE BUTTERYFLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL LUMEN INSERTION TRAY KENDALL DUAL LUMEN CATHETER LJS TYCO/KENDALL HEALTHCARE 43311 522918

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN