BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 23083623 · Received September 18, 2025

    Report

    Report Number
    9680904-2025-00027
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 28, 2025
    Report Date
    October 10, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403090707
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE PHYSICAL SAMPLE WAS NOT RETURNED FOR EVALUATION WHICH LIMITED THE ABILITY TO CONFIRM WHETHER THE DEVICE WAS PREVIOUSLY USED. ONE PHOTO IMAGE WAS RECEIVED AND REVIEWED. THE PHOTO SHOWED A REDDISH-DARK FLUID INSIDE THE DRAINAGE TUBING, WITH DENSE OR CLOUDY AREAS THAT MAY SUGGEST THE PRESENCE OF FAT OR BLOOD CLOTS. THE FLUID'S APPEARANCE IS CONSISTENT WITH BLOOD OR A MIXTURE OF BODILY FLUIDS. BASED ON THE IMAGE, THE FLUID IS LOCATED NEAR THE BEGINNING OF THE TUBING, SUGGESTING THAT THE CUSTOMER HAD JUST STARTED USING THE BOTTLE AT THE TIME THE PHOTO WAS TAKEN. THE FLUID OBSERVED APPEARED TO BE BLOOD WITH CLOTS OR ACCUMULATED FAT, WHICH IS A NORMAL CHARACTERISTIC OF BODILY FLUIDS AND CANNOT BE CONFIRMED AS A FOREIGN PARTICLE. THE PRESENCE OF FLUID IN THE TUBING DOES NOT NECESSARILY INDICATE PRIOR USE, AS IT MAY HAVE OCCURRED DURING THE INITIAL DRAINAGE PROCESS. BASED ON THE IMAGE EVALUATION AND THE ABSENCE OF A RETURNED SAMPLE, THE REPORTED FAILURE MODE CANNOT BE CONFIRMED. THE FLUID CHARACTERISTICS OBSERVED ARE CONSISTENT WITH EXPECTED DRAINAGE CONTENTS AND DO NOT PROVIDE SUFFICIENT EVIDENCE OF CONTAMINATION OR PRIOR USE. BASED ON THE INVESTIGATION PERFORMED, A PROBABLE ROOT CAUSE COULD NOT BE ESTABLISHED DURING THE ANALYSIS PERFORMED WITH THE INFORMATION AVAILABLE AS NO ISSUES WERE FOUND. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 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. D3 (MEDICAL DEVICE MANUFACTURER), 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). G4: PMA / 510(K)#: K160437; K160450; K201155; K241946. INITIAL MDR MFR REPORT 9680904-2025-00027, SITE LEGAL NAME (FDA) REPORTED, CAREFUSION D.R. 203 LTD. - SANTO DOMINGO, DOMINICAN REPUBLIC; SITE REGISTRATION NUMBER (FDA) 9680904. CORRECT SITE LEGAL NAME (FDA) IS, VERNON HILLS; SITE REGISTRATION NUMBER (FDA) 1423507. 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: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. A PHOTO WAS PROVIDED. PHOTO REVIEW IS UNDER WAY. THE INVESTIGATION IS CURRENTLY UNDERWAY. H3 (DEVICE EVAL BY MANUFACTURER) A DEVICE HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D2: PROCODE: DWM; PNG. G4: 510K: K160437; K160450; K201155. 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 THE PLEURX DRAINAGE KIT WAS FOUND TO BE CONTAMINATED AND APPEARED TO HAVE ALREADY BEEN USED. ANOTHER DEVICE WAS USED TO DRAIN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLEURX DRAINAGE KIT WAS FOUND TO BE CONTAMINATED AND APPEARED TO HAVE ALREADY BEEN USED. ANOTHER DEVICE WAS USED TO DRAIN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552951 PLEURX DRAINAGE KIT 1000ML APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001605769 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown