BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 24434796 · Received February 24, 2026

    Report

    Report Number
    1423507-2026-00033
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 25, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    PNG
    UDI-DI
    10885403090707
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: A LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD IS CURRENTLY UNDERWAY. PHOTOS WERE PROVIDED AND REVIEW IS CURRENTLY PENDING. H3 (DEVICE EVAL BY MANUFACTURER) A DEVICE HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G4: PMA/510K: K160437; K160450; K201155; K241946. D2B: PRO CODE: DWM; PNG. SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: TWO PHOTO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTOS, A LEAK WAS OBSERVED AT THE INTERFACE BETWEEN THE ACCESS DILATOR AND THE DRAINAGE LINE TUBING. THE IMAGES SUGGEST AN INCOMPLETE BOND AT THIS CONNECTION POINT. SPECIFICALLY, THERE APPEARS TO BE INSUFFICIENT APPLICATION OF SOLVENT, GLUE DURING THE MANUFACTURING PROCESS, WHICH LIKELY RESULTED IN A GAP BETWEEN THE TUBING AND THE ACCESS DILATOR. BASED ON THE VISUAL INSPECTION PERFORMED, THE FAILURE MODE IS CONSISTENT WITH AN INADEQUATE SOLVENT, GLUE APPLICATION AT THE TUBING TO ACCESS DILATOR CONNECTION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001631079 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, A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE WAS IDENTIFIED AS EITHER A HUMAN FACTOR ISSUE OR A MANUFACTURING ASSEMBLY ERROR. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND AWARENESS AND REINFORCEMENT ACTIONS HAVE BEEN IMPLEMENTED TO ENSURE ADHERENCE TO ASSEMBLY REQUIREMENTS AND MINIMIZE THE LIKELIHOOD OF RECURRENCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6: ANNEX G (COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2026, THE DURING ROUTINE PLEURX DRAIN CARE, STAFF NOTICED A WET SPOT ON THE STERILE DRAPE. UPON INSPECTION, THEY FOUND THAT THE TUBING ATTACHED TO THE PLEURX BOTTLE WAS LEAKING FLUID ONTO THE STERILE FIELD. THE DRAINAGE PROCEDURE WAS STOPPED, THE LEAKING BOTTLE WAS DISCONNECTED, AND A NEW BOTTLE AVAILABLE IN THE HOME WAS ATTACHED. THE DEVICE INVOLVED WAS NOT IMPLANTED AND NOT RETAINED. NO PATIENT INJURY WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE LEAKAGE OCCURRED BETWEEN THE DISTAL END OF THE ACCESS TIP AND THE ATTACHED DRAINAGE LINE. THERE WAS NO DAMAGE NOTED TO THE ACCESS TIP OR THE PATIENT'S VALVE. THE PATIENT'S CATHETER IS AN ABDOMINAL PLEURX ON THEIR RIGHT SIDE. DUE TO THE LEAKAGE, BODILY FLUID LEAKED ON TO PATIENT'S LAP, SATURATING A SMALL PORTION OF THEIR PANTS AND ON TO THEIR CHAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2026, THE DURING ROUTINE PLEURX DRAIN CARE, STAFF NOTICED A WET SPOT ON THE STERILE DRAPE. UPON INSPECTION, THEY FOUND THAT THE TUBING ATTACHED TO THE PLEURX BOTTLE WAS LEAKING FLUID ONTO THE STERILE FIELD. THE DRAINAGE PROCEDURE WAS STOPPED, THE LEAKING BOTTLE WAS DISCONNECTED, AND A NEW BOTTLE AVAILABLE IN THE HOME WAS ATTACHED. THE DEVICE INVOLVED WAS NOT IMPLANTED AND NOT RETAINED. NO PATIENT INJURY WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE LEAKAGE OCCURRED BETWEEN THE DISTAL END OF THE ACCESS TIP AND THE ATTACHED DRAINAGE LINE. THERE WAS NO DAMAGE NOTED TO THE ACCESS TIP OR THE PATIENT'S VALVE. THE PATIENT'S CATHETER IS AN ABDOMINAL PLEURX ON THEIR RIGHT SIDE. DUE TO THE LEAKAGE, BODILY FLUID LEAKED ON TO PATIENT'S LAP, SATURATING A SMALL PORTION OF THEIR PANTS AND ON TO THEIR CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3189 PLEURX DRAINAGE KIT 1000ML PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING PNG CAREFUSION, INC 0001631079 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown