BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURX LOCKABLE DRAINAGE LINE KIT

    MDR report key: 23957141 · Received January 5, 2026

    Report

    Report Number
    1423507-2025-00189
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 3, 2025
    Report Date
    January 31, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403502392
    PMA / PMN Number
    SEE H.11.
    Adverse Event
    Yes
    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: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. A PHOTO WAS PROVIDED FOR REVIEW, AND REVIEW IS CURRENTLY UNDERWAY. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D2B: MEDICAL DEVICE TYPE: DWM; PNG, G4: PMA / 510(K)#: K160450; K201155; K241946. 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.

    Additional Manufacturer Narrative · 0

    H11: PHYSICAL SAMPLES WERE NOT RECEIVED FOR EVALUATION. ONE PHOTO PROVIDED BY THE CUSTOMER WAS RECEIVED AND REVIEWED. DURING PHOTO REVIEW, IN THE IMAGE, THE LOCKING ACCESS DILATOR WAS OBSERVED SEPARATED FROM THE DRAINAGE LINE TUBE. SMALL TRACES OF SOLVENT/ADHESIVE WERE VISIBLE, INDICATING THE TUBE HAD BEEN PREVIOUSLY BONDED TO THE DILATOR. BASED ON THE INVESTIGATION PERFORMED AND THE INFORMATION AVAILABLE AT THE TIME, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. NO DISCREPANCIES WERE FOUND DURING THE ANALYSIS, AND IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE WERE MET. IT REMAINS UNKNOWN WHETHER PROCEDURAL DEVIATIONS CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001617606 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. INCOMING INSPECTION RECORDS FOR RAW MATERIALS WERE ALSO REVIEWED, AND NO NON-CONFORMANCE REPORTS (NCRS) OR OTHER QUALITY ISSUES RELATED TO THIS INCIDENT WERE IDENTIFIED. A REVIEW OF CURRENT MANUFACTURING CONTROLS WAS CONDUCTED. WORK INSTRUCTION WAS VERIFIED TO INCLUDE ALL REQUIRED STEPS FOR CORRECTLY ASSEMBLING THE LOCKING ACCESS DILATOR TO THE TUBING, ENSURING PROPER INSERTION INTO THE LOCKING FEATURE AND A COMPLETE BOND BETWEEN COMPONENTS. POST ASSEMBLY CHECKS REQUIRE VERIFICATION THAT THE ASSEMBLY IS FREE OF RESIDUES AND MEETS APPLICABLE QUALITY CRITERIA. THE INSTRUCTION INCLUDES VISUAL AIDS TO SUPPORT DEFECT IDENTIFICATION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITIONS WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. B3 (DATE OF EVENT) THE ACTUAL DATE OF EVENT IS UNKNOWN, 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 THAT THERE WERE ISSUES WITH THE PLEURX LOCKABLE DRAINAGE LINE KIT. DURING FOLLOW UP RESPONSE RECEIVED ON (B)(6) 2025, IT WAS FURTHER REPORTED THAT THE ¿MALE¿ CONNECTOR USED TO PLUG INTO THE PLEURX WAS NOT WATERPROOF AND CAME LOOSE EASILY, CAUSING LEAKAGE WHEN CONNECTING A PLEURX TO A PLEUR-EVAC. INITIALLY, THERE WAS NO VISIBLE DEFECT, BUT THE ISSUE BECAME APPARENT DURING USE. MULTIPLE KITS HAD TO BE OPENED BEFORE FINDING A FUNCTIONAL TUBING. THERE WAS A RISK OF PNEUMOTHORAX AND INFECTION SINCE THE SET UP WAS NOT A CLOSED SYSTEM ANYMORE. PATIENT PROBABLY KEPT HIS PLEURX CONNECTED TO A PLEUR-EVAC FOR LONGER. AN X-RAY WAS ORDERED, AND THE PATIENT WAS ALREADY ON ANTIBIOTICS. BASED ON FURTHER RESPONSE ON (B)(6) 2025 IT WAS FURTHER MENTIONED THE RESULTS OF THE X-RAY HAD A NEW SMALL PNEUMOTHORAX AND THAT THIS WAS POSSIBLY RELATED TO THE DEVICE FAILURE. ADDITIONAL INTERVENTION WAS NOT REQUIRED; THE DEFECTIVE TUBING WAS REPLACED WITH INTACT TUBING TO CONTINUE CONTINUOUS DRAINAGE VIA THE PLEURX. THE PATIENT WAS ALREADY ON ANTIBIOTICS FOR INFECTION IN THE PLEURAL EFFUSION FOR SEVERAL DAYS AT THE TIME OF THE INCIDENT, SO THE ANTIBIOTICS WERE EXTENDED DUE TO THIS INCIDENT. IT WAS NOTED THAT THIS TUBING IS RARELY USED FOR LONG-TERM AND MAINLY USED FOR THE DURATION OF A TEMPORARY DRAINAGE, BUT SOMETIMES IT IS LEFT IN PLACE FOR CONTINUOUS DRAINAGE WITH PLEUR-EVAC (AS IN THIS CASE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ISSUES WITH THE PLEURX LOCKABLE DRAINAGE LINE KIT. DURING FOLLOW UP RESPONSE RECEIVED ON DECEMBER 8, 2025, IT WAS FURTHER REPORTED THAT THE ¿MALE¿ CONNECTOR USED TO PLUG INTO THE PLEURX WAS NOT WATERPROOF AND CAME LOOSE EASILY, CAUSING LEAKAGE WHEN CONNECTING A PLEURX TO A PLEUR-EVAC. INITIALLY, THERE WAS NO VISIBLE DEFECT, BUT THE ISSUE BECAME APPARENT DURING USE. MULTIPLE KITS HAD TO BE OPENED BEFORE FINDING A FUNCTIONAL TUBING. THERE WAS A RISK OF PNEUMOTHORAX AND INFECTION SINCE THE SET UP WAS NOT A CLOSED SYSTEM ANYMORE. PATIENT PROBABLY KEPT HIS PLEURX CONNECTED TO A PLEUR-EVAC FOR LONGER. AN X-RAY WAS ORDERED, AND THE PATIENT WAS ALREADY ON ANTIBIOTICS. BASED ON FURTHER RESPONSE ON (B)(6) 2025 IT WAS FURTHER MENTIONED THE RESULTS OF THE X-RAY HAD A NEW SMALL PNEUMOTHORAX AND THAT THIS WAS POSSIBLY RELATED TO THE DEVICE FAILURE. ADDITIONAL INTERVENTION WAS NOT REQUIRED; THE DEFECTIVE TUBING WAS REPLACED WITH INTACT TUBING TO CONTINUE CONTINUOUS DRAINAGE VIA THE PLEURX. THE PATIENT WAS ALREADY ON ANTIBIOTICS FOR INFECTION IN THE PLEURAL EFFUSION FOR SEVERAL DAYS AT THE TIME OF THE INCIDENT, SO THE ANTIBIOTICS WERE EXTENDED DUE TO THIS INCIDENT. IT WAS NOTED THAT THIS TUBING IS RARELY USED FOR LONG-TERM AND MAINLY USED FOR THE DURATION OF A TEMPORARY DRAINAGE, BUT SOMETIMES IT IS LEFT IN PLACE FOR CONTINUOUS DRAINAGE WITH PLEUR-EVAC (AS IN THIS CASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18362 PLEURX LOCKABLE DRAINAGE LINE KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001617606 10885403502392

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other