BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 16385290 · Received February 16, 2023

    Report

    Report Number
    9680904-2023-00008
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 8, 2023
    Report Date
    April 20, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403090707
    PMA / PMN Number
    K160437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 7171133 FOLLOW-UP EMDR FOR DEVICE EVALUATION: FIFTEEN PHYSICAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES ARE ACCESS TIP PIECES CUT FROM THE BOTTLE. NO OTHER COMPONENTS WERE RETURNED. A VISUAL INSPECTION WAS PERFORMED TO THE RETURNED SAMPLES AND NO FLASH OR EXCESSIVE MATERIAL WAS NOTED ALONG THE BODY OR AT THE TIP OF THE ACCESS TIP. A FUNCTIONAL INSPECTION WAS PERFORMED IN WHICH THE ACCESS TIPS WERE CONNECTED TO A PLEURX CATHETER. ALL SAMPLES CLICKED INTO THE CATHETER AND ATTACHED SECURELY TO IT; THEREFORE, THE REPORTED FAILURE MODE WAS NOT CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE LOT 0001456546 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE IDENTIFIED THAT, MANPOWER AND METHOD ARE CONSIDERED CONTRIBUTOR FACTORS FOR THE NON-CONFORMANCE AND MACHINE IS CONSIDERED THE MAIN ROOT CAUSE, SINCE IT WAS CONCLUDED THAT WEAR ON THE BLOCKS AND CAVITIES OF THE MOLD COULD PROVOKE THE FLASH DEFECT. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE AND ADDRESS THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED FOR FUTURE OCCURRENCES.

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A051102. PATIENT PROBLEM CODE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PATIENT HARM. EVENT DESCRIPTION STATES: AIR LEAK AROUND THE ACCESS TIP AND THE PATIENT WALL TIP. QUESTIONS/INQUIRIES: - WHERE DID LEAKAGE OCCURRED? THE AIR LEAKAGE OCCURRED AT THE ACCESS TIP AND THE ACCESS TIP OF THE CATHETER COMING OUT OF THE PATIENT WALL. - IS THIS AT THE ACCESS TIP AND THE CATHETERS VALVE? YES IF IT AT THE ACCESS TIP DID THE ACCESS TIP FULLY CLICKED IN TO THE VALVE? YES. - DID THE LEAKAGE OCCURRED TO THE DRAINAGE LINE TO THE BOTTLE? NO. - WAS THERE DAMAGE NOTED ON THE ACCESS TIP OR PATIENT'S VALVE? ACCESS TIP, PATIENT FELT IT WAS MOLDING/ FLASHING DEFECTIVE. - WHERE IS THE CATHETER LOCATED? CHEST. - IS THERE A SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? YES. - WHAT WAS THE IMPACT TO THE PATIENT? NONE.

    Description of Event or Problem · 0

    IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: AIR LEAK AROUND THE ACCESS TIP AND THE PATIENT WALL TIP. QUESTIONS/INQUIRIES: WHERE DID LEAKAGE OCCURRED? THE AIR LEAKAGE OCCURRED AT THE ACCESS TIP AND THE ACCESS TIP OF THE CATHETER COMING OUT OF THE PATIENT WALL. IS THIS AT THE ACCESS TIP AND THE CATHETERS VALVE? YES. IF IT AT THE ACCESS TIP DID THE ACCESS TIP FULLY CLICKED IN TO THE VALVE? YES. DID THE LEAKAGE OCCURRED TO THE DRAINAGE LINE TO THE BOTTLE? NO. WAS THERE DAMAGE NOTED ON THE ACCESS TIP OR PATIENT'S VALVE? ACCESS TIP, PATIENT FELT IT WAS MOLDING/ FLASHING DEFECTIVE. WHERE IS THE CATHETER LOCATED? CHEST. IS THERE A SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? YES. WHAT WAS THE IMPACT TO THE PATIENT? NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373538 PLEURX DRAINAGE KIT 1000ML APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 50-7510 0001456546 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other