BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER EXT SET W/LUER ACTIVATED VALVE DOR IV ACCE

    MDR report key: 1236459 · Received November 20, 2008

    Report

    Report Number
    6000001-2007-04469
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 19, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THE DEVICE WAS LISTED AS UNAVAILABLE AS IT WAS STILL IN USE. HOWEVER, DURING FOLLOW UP THE CUSTOMER STATED THAT THE SAMPLE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. A BATCH REVIEW CANNOT BE CONDUCTED, AS THE CUSTOMER WAS NOT ABLE TO PROVIDE A LOT NUMBER. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    MATERIALS MANAGER REPORTS LEAKAGE IS OCCURRING AT THE MALE END OF THE TUBING THAT GOES INTO THE IV CANNULA DURING PATIENT USE. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER EXT SET W/LUER ACTIVATED VALVE DOR IV ACCE CLEARLINK FPA BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1