BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 3825281 · Received May 21, 2014

    Report

    Report Number
    1625685-2014-00117
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. CONSEQUENTLY, THE QUALITY OF THE PRODUCT COULD NOT BE EVALUATED. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED PATIENT CONDITION. EVERY CATHETER ASSEMBLY IS SUBJECTED TO EXTENSIVE FUNCTIONAL TESTING AND INSPECTION DURING THE ASSEMBLY PROCESS TO VERIFY PERFORMANCE AND CONFORMITY TO ENGINEERING DESIGN. LIKEWISE, A REVIEW OF ALL MANUFACTURING METHODS AND PERSONNEL INVOLVED IN THE ASSEMBLY OF THE DEVICE DETERMINED THERE WAS NO CONTRIBUTION FROM EITHER TO THE REPORTED CONDITION. A REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INVOLVED COULD NOT BE PERFORMED AS LOT NUMBER INFORMATION WAS NOT AVAILABLE. HOWEVER, A RETROSPECTIVE REVIEW OF STERILIZATION RECORDS FOR A PERIOD OF 24-MONTHS ((B)(4) 2012 ¿ (B)(3) 2014) FOR ALL CATALOG CODES AND LOTS WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY DEVIATION WHICH WAS DETERMINED TO AFFECT THE EFFECTIVENESS OF THE TERMINAL STERILIZATION PROCESS. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THE PRODUCT CONFIRMED THAT THE IFU IS ROBUST AND DIRECTS THE USER OF THE PRODUCT ON THE PROPER TECHNIQUE AND PROPER DEPTH FOR THE PLACEMENT OF THE CATHETER. ADDITIONALLY, ALL MATERIALS USED IN THE 50-7000B PLEURX TRAY ARE ALL OF INDUSTRY STANDARD MEDICAL GRADE AND TESTED PER ISO10993 REQUIREMENTS. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS THE SAMPLE WAS NOT AVAILABLE FOR ANALYSIS. THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THIS ISSUE TO IDENTIFY ANY TREND AND/OR THE NEED FOR ANY FURTHER ACTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT DEVELOPED A LOCAL TUNNEL TRACK INFECTION 2-3 MONTHS POST PLACEMENT. THE TUNNEL TRACK WAS HEALED AND THERE WAS NO EVIDENCE OF PLEURAL FLUID OOZING AROUND THE CATHETER. THE INFECTION RESPONDED TO ANTIBIOTICS AND THE PATIENT HAD PLACEMENT AND WAS DISCHARGED TO HOME CARE SERVICES. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. PER CUSTOMER (B)(6), NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303059 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7000B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention