BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITX PERITONEAL CATHETER & STARTER KIT

    MDR report key: 23219102 · Received October 6, 2025

    Report

    Report Number
    1423507-2025-00072
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 11, 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
    AZ, US
    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. B3 (DATE OF EVENT) THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER (AWARENESS DATE) WAS ENTERED INTO THE DATE OF EVENT FIELD. G4: PMA/510K: 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: TWO PHOTOS SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR EVALUATION. WE CAN CONFIRM THAT THE INCORRECT CARTON IS PRESENT. THE PRODUCT WAS PACKAGED INTO THE INCORRECT CARTON; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. IN ONE PHOTO, WHAT APPEARS TO BE THE CORRECT CARTOON CAN BE SEEN WITH A DIFFERENT LOT NUMBER. (ADDITIONAL PHOTOS THAT WOULD INCLUDE THE CARTON LABELING WOULD BE NEEDED TO DEFINITIVELY CONFIRM). 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. THE COMPLAINT HAS BEEN LOGGED IN THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE MONITORED THROUGH TRACKING, TRENDING, AND QUALITY DATA ANALYSIS FOR POTENTIAL FUTURE OCCURRENCES.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 THE CUSTOMER ORDERED ITEM: 50-9900C (PERITX PRODUCT) BUT RECEIVED ONE UNIT PACKAGED IN PLEURX BOXES. THE ISSUE WAS DETECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER ORDERED ITEM 50-9900C (PERITX PRODUCT), BUT RECEIVED ONE UNIT PACKAGED IN PLEURX BOXES. THE ISSUE WAS DETECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692678 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 Other