BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 2950350 · Received February 8, 2013

    Report

    Report Number
    1625685-2013-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. CONSEQUENTLY, THE QUALITY OF THE PRODUCT COULD NOT BE EVALUATED IN REGARDS TO THE REPORTED ISSUE. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. EVERY CATHETER ASSEMBLY IS SUBJECTED TO EXTENSIVE FUNCTIONAL TESTING AND INSPECTION DURING THE ASSEMBLY PROCESS TO VERIFY PERFORMANCE AND CONFORMITY TO ENGINEERING DESIGN. ANY FAILURES WOULD BE IMMEDIATELY CULLED FROM PRODUCTION AND SCRAPPED. A REVIEW OF INTERNAL PRODUCTION RECORDS FOR THE LOT NUMBER INVOLVED COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS REPORT IN AN EFFORT TO HEIGHTEN AWARENESS REGARDING THIS ISSUE AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES. ALTHOUGH THE REPORTED CONDITION COULD NOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITHOUT A SAMPLE BEING PROVIDED, THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.

    Description of Event or Problem · 1

    THE CUFF STAYED IN THE PATIENT WHEN THE PHYSICIAN REMOVED THE CATHETER.  THE CUFF WILL REMAIN IN THE PATIENT. THE PHYSICIAN CONSULTED WITH A CAREFUSION CLINIAL NURSE AND THE SALES REPRESENTATIVE. ON (B)(6) 2013, THE SALES REPRESENTATIVE (B)(6) PROVIDED THE FOLLOWING INFORMATION: THE SPECIFIC TIME FRAME THE CATHETER WAS IN PLACE IS UNKNOWN BUT IT WAS SHORT TERM. THIS WAS A PATIENT WITH A NON-MALIGNANT PLEURAL EFFUSION. THE CATHETER WAS USED POST CARDIO THORACIC SURGERY, SO NOT A LOT OF TIME PASSED BETWEEN WHEN THE PATIENT'S FLUID DRIED UP AND WHEN THE CATHETER WAS REMOVED. NO OTHER PART OF THE CATHETER WAS LEFT INSIDE THE PATIENT, AND THE CUFF DID NOT TEAR, THE WHOLE CUFF WAS LEFT BEHIND. THE SALES REPRESENTATIVE CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THE EVENT. THE CATHETER WAS DISCARDED BY THE SURGEON AND THE LOT IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55060 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7000B

    Patients

    Seq Age Sex Outcome Treatment
    1