BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 2935667 · Received January 30, 2013

    Report

    Report Number
    1625685-2013-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K052436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CONDITION. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. EVERY VALVE/CATHETER ASSEMBLY IS SUBJECTED TO EXTENSIVE FUNCTIONAL TESTING AND INSPECTION DURING THE ASSEMBLY PROCESS TO VERIFY PERFORMANCE AND CONFORMITY TO ENGINEERING DESIGN. A THOROUGH REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD (DHR), RAW MATERIAL HISTORY FILES, AND STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOT WAS COMPLETED AND NON-CONFORMANCES WERE NOTED; HOWEVER, ONLY ONE OF THESE NON-CONFORMANCES COULD BE RELATED TO THE REPORTED CONDITION. AT THE TIME OF PRODUCTION, THE NON-CONFORMANCE INVOLVING THE ACCESS VALVES WAS PROPERLY COMMUNICATED TO THE VALVE SUPPLIER PER CURRENT PROCEDURES. EACH NON-CONFORMANCE, INCLUDING THE ONE INVOLVING THE ACCESS VALVES, WAS HANDLED APPROPRIATELY AS PRODUCT WAS SAMPLED AND SUBMITTED TO QUALITY ASSURANCE FOR FURTHER INSPECTION, EVALUATION, AND RELEASE. ONE HUNDRED PERCENT (100%) PRESSURE DECAY TESTING WAS PERFORMED, VERIFYING THAT THE ACCESS VALVES DO NOT LEAK FOR THE ENTIRE LOT INVOLVED PRIOR TO FINAL PLEURAL CATHETER ASSEMBLY. ALL DEFECTIVE UNITS WERE CULLED AND SCRAPPED. THE TESTING WAS SUCCESSFULLY PERFORMED. PROPER ASSEMBLY VERIFICATION OF THE ACCESS VALVES IS COMPLETED BY THE SUPPLIER PRIOR TO DELIVERY TO THE CAREFUSION MANUFACTURING FACILITY. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURES. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS FAILURE MODE SINCE 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 FOR THIS PARTICULAR INCIDENT 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

    IT WAS REPORTED THAT THE VALVE BROKE OFF. NO PATIENT INJURY, ALTHOUGH IT WAS CONSIDERED CONTAMINATED. ON (B)(6) 2013, THE LPN WHO WAS PRESENT DURING THE PROCEDURE INDICATED THAT WHEN THE PHYSICIAN WAS THREADING THE CATHETER AND INSERTING IT INTO THE PATIENT, THE PHYSICIAN NOTICED A LOOSE, SMALL BLUE PIECE IN THE CATHETER AND THE PHYSICIAN COULD SEE THAT IT WAS THE VALVE THAT WAS BROKEN. NO BLUE PIECE TOUCHED THE PATIENT AND THE WHOLE CATHETER WAS TAKEN OUT AND REPLACED WITH ANOTHER CATHETER WITHOUT ANY FURTHER ISSUES. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41291 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7000B 0000452184

    Patients

    Seq Age Sex Outcome Treatment
    1