BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATH, MINI

    MDR report key: 1952427 · Received January 7, 2011

    Report

    Report Number
    1625685-2011-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE COMPLAINT SAMPLE IDENTIFIED DAMAGE TO THE DUCK-BILL VALVE IN THE VALVE ASSEMBLY. THE DUCK-BILL VALVE HAD DAMAGE ON THE SIDE OF THE VALVE. THE EVALUATION ALSO NOTED THAT THE DUCK-BILL VALVE HAD BEEN MOVED IN THE ASSEMBLY. THE VALVE ASSEMBLY WAS TESTED USING THE USON PRESSURE DECAY TESTING CURRENTLY USED TO 100% FUNCTIONALLY TEST ALL VALVE ASSEMBLIES DURING MANUFACTURING. THE COMPLAINT SAMPLE VALVE FAILED THE PRESSURE TEST. THE SOURCE OF THE DAMAGE COULD NOT BE CONFIRMED BY THIS COMPLAINT INVESTIGATION. A POTENTIAL SOURCE FOR THE OBSERVED DAMAGE ON THE VALVE ASSEMBLY MAY BE DUE TO THE INSERTION OF A FOREIGN OBJECT INTO THE VALVE ASSEMBLY OTHER THAN THE ACCESS DILATOR PROVIDED WITH THE PRODUCT AS INDICATED IN THE DIRECTIONS FOR USE. HOWEVER, WE ARE UNABLE TO CONFIRM THIS INFORMATION FROM THE COMPLAINT. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY INSPECTION PLANS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE IDENTIFIED DEFECT. 100% OF VALVE ASSEMBLIES ARE SUBJECTED TO A FUNCTIONAL PRESSURE TEST DURING THE ASSEMBLY PROCESS TO VERIFY PERFORMANCE. ANY FAILURES WOULD BE IMMEDIATELY CULLED FROM PRODUCTION AND SCRAPPED. A THOROUGH COMPLAINT HISTORY REVIEW WAS COMPLETED AND DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES.

    Description of Event or Problem · 1

    CATHETER WAS PLACED AND ONCE THE DRAINAGE WAS COMPLETED FLUID THEN SPRAYED OUT OF THE VALVE WHEN THE PATIENT COUGHED. THE CATHETER WAS IMMEDIATELY CLAMPED, REMOVED AND REPLACED BY ANOTHER PLEURAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATH, MINI PLEURX PLEURAL CATH, MINI DWM CAREFUSION 50-7050 L9E288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other