BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN CATHETERS

    MDR report key: 3143191 · Received May 29, 2013

    Report

    Report Number
    3143191
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 24, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE COMPANY THAT OUR FACILITY WAS EXPERIENCING CATHETER KINKING. THE COMPANY MARKETING DEPARTMENT HAS RECOGNIZED THE ISSUE STATED THAT DURING THE STERILIZATION PROCESS THE BLUE TUBING HAS BECOME MORE FLEXIBLE. THEY FURTHER STATED THAT THE COMPANY IS IN THE PROCESS OF CHANGING THAT PIECE TO A THICKER CLEAR TUBING THAT IS THE SAME AS THE REST OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234453 COVIDIEN CATHETERS NONE FJS COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other