BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 500ML 10/CS

    MDR report key: 22611080 · Received July 25, 2025

    Report

    Report Number
    9680904-2025-00020
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 23, 2025
    Report Date
    September 30, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    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: A DEVICE HISTORY REVIEW WAS PERFORMED AS THE LOT NUMBER WAS PROVIDED. THE DEVICE HISTORY REVIEW FOR THE REPORTED LOT NUMBER DID NOT SHOW ANY QUALITY ISSUES RELATED TO THE REPORTED INCIDENT. 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. NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). INITIAL MDR MFR REPORT # 9680904-2025-00020, 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: A LOT NUMBER WAS PROVIDED; THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. 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. D2B: PRO CODE: DWM; PNG, G4: PMA/510(K): K160437; K160450; K201155; K971753. 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 DURING USE OF THE PLEURX DRAINAGE KIT THE ACCESS TIP WAS FOUND BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE PLEURX DRAINAGE KIT THE ACCESS TIP WAS FOUND BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381956 PLEURX DRAINAGE KIT 500ML 10/CS APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001604702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown