BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 1973908 · Received January 31, 2011

    Report

    Report Number
    1625685-2011-00005
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 28, 2011
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 SHOWED A PUNCTURE ON THE TOP OF THE VALVE. THE VALVE ASSEMBLY WAS TESTED USING THE USON PRESSURE DECAY TESTING CURRENTLY USED TO 100% FUNCTIONALLY TEST ALL VALVE ASSEMBLIES DURING MANUFACTURING PRIOR TO RELEASE. THE COMPLAINT SAMPLE VALVE FAILED THE PRESSURE DECAY TEST. THE SOURCE OF THE DAMAGE COULD NOT BE CONFIRMED BY THIS COMPLAINT INVESTIGATION. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY INSPECTION PLANS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE IDENTIFIED DEFECT. EVERY VALVE ASSEMBLY IS SUBJECTED TO A FUNCTIONAL PRESSURE DECAY TEST DURING THE ASSEMBLY PROCESS TO VERIFY PROPER PERFORMANCE (NO LEAKS). ANY FAILING UNIT WOULD BE IMMEDIATELY SEGREGATED FROM PRODUCTION AND SCRAPPED. THEREFORE; BASED ON THIS INFORMATION WE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE DAMAGED VALVE.

    Description of Event or Problem · 1

    LEAKING VALVE AT TIME OF PLACEMENT. DR. (B)(6) NOTICED LEAKING VALVE, SHE PULLED IT AND REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATHETER KIT PLEURX PLEURAL CATHETER KIT DWM CAREFUSION 50-7000B L0P127

    Patients

    Seq Age Sex Outcome Treatment
    1