BEUDAMED
    FDA Adverse Event Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 3092644 · Received May 3, 2013

    Report

    Report Number
    1625685-2013-00009
    Date Received
    May 3, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE (1) FILTER STRAW WAS RECEIVED FOR EVALUATION. EXAMINATION OF THE COMPLAINT SAMPLE CONFIRMED THE REPORTED CONDITION AS THE LUMEN OF THE FILTER STRAW CANNULA WAS COMPLETELY OCCLUDED. THE NATURE OF THE OCCLUSION IS UNKNOWN. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. IN ADDITION, 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. A REVIEW OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURES. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE WAS IDENTIFIED AS A SUPPLIER RELATED ISSUE. THE FILTER STRAW IS SUPPLIED BY AN EXTERNAL VENDOR (B. BRAUN) AND THE LUMEN OF THE CANNULA¿S INTERNAL DIAMETER FEATURE IS NOT ALTERED BY THE CAREFUSION FACILITY PRIOR TO PLACEMENT IN THE FINAL PACKAGING. THIS REPORT WILL BE ENTERED INTO THE SUPPLIER CORRECTIVE ACTION NOTIFICATION TRACKING SYSTEM PER PROCEDURE. THE SUPPLIER OF THE FILTER STRAW ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE AND THE COMPLAINT SAMPLE WILL BE PROVIDED TO THE SUPPLIER FOR ANALYSIS TO IDENTIFY ANY MANUFACTURING DEFECTS AND APPLICABLE CORRECTIVE AND PREVENTIVE ACTIONS. ALL APPLICABLE CAREFUSION QUALITY PERSONNEL WILL BE NOTIFIED OF THIS REPORT IN AN EFFORT TO HEIGHTEN AWARENESS REGARDING THIS POTENTIAL DEFECT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FILTER STRAW WAS OCCLUDED. THE PHYSICIAN WAS UNABLE TO ASPIRATE OR FLUSH. ON (B)(6) 2013, THE CUSTOMER ((B)(6)) PROVIDED THE FOLLOWING INFORMATION: THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER KIT. THE CUSTOMER INDICATED THE PATIENT HAD TO BE UNDER CONSCIOUS SEDATION (WITH VERSED AND FENTANYL) APPROXIMATELY 15-20 MINUTES LONGER; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. ON (B)(6) 2013, THE CUSTOMER CONFIRMED THE ONLY DEFECT NOTED BY THE USER WAS THAT THE FILTER STRAW WAS OCCLUDED. THERE WAS NOTHING WRONG WITH THE CATHETER OR ITS FENESTRATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193953 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7000B 0000508045

    Patients

    Seq Age Sex Outcome Treatment
    1 Other