BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 1694849 · Received May 14, 2010

    Report

    Report Number
    1625685-2010-00019
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    February 25, 2010
    Report Date
    May 13, 2010
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT SAMPLE WAS PROVIDED BY THE CUSTOMER AND SUBSEQUENTLY EVALUATED THROUGH VISUAL INSPECTION BY CAREFUSION QUALITY ENGINEERING. THE VISUAL INSPECTION CONFIRMED THAT THE J-WIRE GUIDEWIRE WAS KINKED. A THOROUGH REVIEW OF THE RAW MATERIAL HISTORY FILES, DEVICE HISTORY RECORD (DHR), AND STERILIZATION BATCH RECORD FOR THE REPORTED LOT NUMBER WAS COMPLETED AND THERE WERE NO NON-CONFORMANCES THAT WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ADDITIONALLY, A THOROUGH REVIEW OF HISTORICAL COMPLAINT DATA FOR THE REPORTED PRODUCT WAS COMPLETED AND NO ADDITIONAL REPORTS OF THIS NATURE HAVE BEEN RECEIVED. THEREFORE, THIS REPORT IS DEEMED TO BE AN ISOLATED OCCURRENCE. A SUPPLIER CORRECTIVE ACTION NOTICE (SCAN) HAS BEEN INITIATED, WHICH NOTIFIED THE SUPPLIER OF THE J-WIRE GUIDEWIRE OF THIS REPORTED DEFECT AND WILL REQUIRE THE SUPPLIER TO COMPLETE A THOROUGH EVALUATION OF THE COMPLAINT SAMPLE, A THOROUGH ROOT CAUSE INVESTIGATION OF THE REPORTED DEFECT, AND APPROPRIATE CORRECTIVE/PREVENTIVE ACTION.

    Description of Event or Problem · 1

    ACCORDING TO THE FDA MAUDE EVENT REPORT FROM THE FDA, "GUIDE WIRE BECAME BENT DURING THE PROCEDURE AND CANNOT BE REUSED, PROLONGED LENGTH OF SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATHETER KIT PLEURX PLEURAL CATHETER KIT DWM CAREFUSION 50-7000B L9L314

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR