BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITX PERITONEAL CATHETER & STARTER KIT

    MDR report key: 23229585 · Received October 6, 2025

    Report

    Report Number
    1423507-2025-00090
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 12, 2025
    Report Date
    January 5, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    PNG
    UDI-DI
    10885403501838
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER REKU0292 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, IT WAS IDENTIFIED THAT THE PROBABLE ROOT CAUSE IS TRACED TO MANUFACTURING RELATED. A FORMAL INVESTIGATION WAS OPENED TO FURTHER INVESTIGATE THESE DEFECTS. 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.

    Additional Manufacturer Narrative · 0

    H11: THE LOT NUMBER FOR THE DEVICE 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. G4: PMA/510(K) #: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER RECEIVED SEVERAL PERITX KITS 50-9900C THAT WERE INCORRECTLY SHIPPED IN PLEURX-LABELED BOXES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER RECEIVED SEVERAL PERITX KITS 50-9900C THAT WERE INCORRECTLY SHIPPED IN PLEURX-LABELED BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7019 PERITX PERITONEAL CATHETER & STARTER KIT PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING PNG CAREFUSION, INC REKU0292 10885403501838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown