BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS TRAY 8FR X 16CM

    MDR report key: 3887313 · Received June 23, 2014

    Report

    Report Number
    1625685-2014-00124
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: ONE (1) PARTIALLY COMPLETE COMPONENT, CATHETER/VALVE ASSEMBLY STC 8FR (PART NUMBER 742-15802), OF AN OPENED UNIT OF A CATALOG CODE PIG1280T (LOT NUMBER 0000640802) DEVICE WAS RECEIVED FOR EVALUATION. THE UNIT WAS MISSING THE PIGTAIL CATHETER BUT DID HAVE THE PACKAGING MATERIAL (TOP WEB) FOR THE SAME PRODUCT CATALOG CODE AND LOT NUMBER. FUNCTIONAL TESTING PERFORMED WITH AN UNUSED PIGTAIL CATHETER ASSEMBLY WAS UNABLE TO REPRODUCE THE REPORTED CONDITION AS NO LEAKS WERE DETECTED AROUND THE VALVE. EXAMINATION OF THE VALVE ASSEMBLY RECEIVED DID NOT REVEAL ANY MANUFACTURING OR FUNCTIONAL DEFECTS THAT MAY LEAD TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS ABLE TO CONFIRM THE VALVE ASSEMBLY DRAINED AS INTENDED. NO LEAKS WERE DETECTED DURING FUNCTIONAL TESTING. THEREFORE, THE EVALUATION WAS UNABLE TO CONFIRM THE REPORTED CONDITION. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. 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 ISSUE. NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. THIS INCLUDES REVIEW OF ALL RAW MATERIAL AND COMPONENTS USED DURING THE MANUFACTURE OF THE LOT INVOLVED. THE CATHETER VALVE ASSEMBLY IS SUPPLIED BY AN EXTERNAL VENDOR AND IS NOT ALTERED BY (B)(4) MANUFACTURING FACILITY PRIOR TO ASSEMBLY INTO THE FINISHED TRAY. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED CONDITION. NO MANUFACTURING, ASSEMBLY OR PERFORMANCE DEFICIENCIES WERE FOUND ON THE SUBMITTED COMPLAINT SAMPLE. THE REPORTED ISSUE HAS BEEN ENTERED INTO THE APPLICABLE TRACKING SYSTEM AND THE SUPPLIER OF THE CATHETER VALVE ASSEMBLY HAS BEEN NOTIFIED OF THE REPORTED ISSUE. THE COMPLAINT SAMPLE HAS ALSO BEEN PROVIDED TO THE SUPPLIER FOR ANY FURTHER APPLICABLE ANALYSIS. THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY ACTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAKING VALVE ON THE DEVICE.  AFTER THE NEEDLE WAS REMOVED, THE SEAL SEEMED TO NOT WORK PROPERLY. THERE WAS NO PATIENT INJURY INVOLVED AS A RESULT OF THIS ISSUE. ON (B)(6) 2014, THE CUSTOMER ((B)(6)) INDICATED THAT THERE WAS NOTHING NOTED OF THE CATHETER OR THE PACKAGING THAT WOULD INDICATE ANYTHING WAS AMISS PRIOR TO USE. THE PROCEDURE BEING PERFORMED WAS A THORACENTESIS AND IT WAS COMPLETED WITH A NEW KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365517 SAFE-T-CENTESIS TRAY 8FR X 16CM NEEDLE, CATHETER GCB CAREFUSION PIG1280T 0000640802

    Patients

    Seq Age Sex Outcome Treatment
    1