BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC

    MDR report key: 23235191 · Received October 7, 2025

    Report

    Report Number
    3006948883-2025-00744
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 26, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 1 VIDEO AND 1 USED SAMPLE. 1)THE RETURNED VIDEO SHOWS THAT THE SEPTUM OF THE SAMPLE HAS BEEN DISLODGED . 2)THE RETURN SAMPLE SHOWS THAT THE SEPTUM HAS BEEN DISLODGED AND THE INJECTION HOLE OF THE CATHETER HUB IS EXPOSED. 3)CHECK THE DISTRIBUTION OF UV ADHESIVE IN THE CATHETER HUB OF THE RETURNED SAMPLE UNDER THE PURPLE LAMP. NO ABNORMALITY IS FOUND IN THE AMOUNT AND DISTRIBUTION OF UV ADHESIVE. 2. DHR/BHR REVIEW(LOT# 5092938): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2025, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2025. WORK ORDER QUANTITY WAS (B)(4) PCS; 2)THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS; 3)THE LEAKAGE TEST RESULTS OF (B)(4) IN PROCESS TESTING AND (B)(4) IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS; 4)NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS; 5) THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS: 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST. THE TESTS ARE PASSED, AND NO LEAKAGE IS FOUND AT THE SEPTUM AND OTHER PARTS OF THE SAMPLE. 4. THE SEPTUM AND THE CATHETER HUB ARE BONDED BY UV ADHESIVE. AFTER THE ADHESIVE IS DRIED, THE VISUAL DETECTION SYSTEM CONDUCTS 100% DETECTION, WHICH WILL AUTOMATICALLY IDENTIFY AND REMOVE DEFECTIVE PRODUCTS. THE VISUAL DETECTION SYSTEM IS CHALLENGED WITH STANDARD SAMPLES EVERY 12 HOURS AND WHEN CHANGING PRODUCT GAUGE TO ENSURE THE EFFECTIVENESS OF THE DETECTION, TO ENSURE ITS ACCURACY AND EFFECTIVENESS. 5. DURING THE USE OF THE PRODUCT, IF THE FLOW RATE IS TOO FAST OR THE PRESSURE IS TOO HIGH, IT MAY ALSO CAUSE DISPLACEMENT OF THE SEPTUM. 6. SKU# 383069 IS A PRODUCT WITH Y PP CONNECTOR, WHICH HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 7. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED SAMPLE SHOWED THAT THE SEPTUM HAD SHIFTED. BY CONDUCTING RELEVANT INSPECTIONS ON THE RETURNED DEFECTIVE SAMPLE: THE DISTRIBUTION OF UV GLUE INSIDE THE CATHETER BASE IS EVEN. AT THE SAME TIME, THE PLANT INSPECTED THE RECORDS OF RAW MATERIALS FOR THIS BATCH OF SEPTUM, USAGE CONDITIONS, AND ON-SITE PRODUCTION RECORDS, AND FOUND NO ABNORMALITIES, NOR ANY MACHINE MALFUNCTIONS, DEVIATIONS, OR REWORK BEHAVIORS. IN ADDITION, THE PLANT CONDUCTED LEAKAGE TESTS ON THE RETAINED SAMPLES FROM THIS BATCH, AND THE RESULTS ALL MET THE STANDARD REQUIREMENTS, WITH NO ANOMALIES OBSERVED. SINCE THE PRODUCT WITH THIS PART NUMBER HAS NOT BEEN DECLARED FOR HIGH-PRESSURE INJECTION USE, AND THE RELATED COMPLAINTS ARE ISOLATED INCIDENTS, IT IS JUDGED THAT THIS COMPLAINT IS A LOW-PROBABILITY EVENT. THEREFORE, IT IS NOT POSSIBLE TO CONFIRM THAT THE FUNDAMENTAL CAUSE OF THIS DEFECT IS RELATED TO PRODUCT QUALITY. THE PLANT WILL CONTINUE TO MONITOR SUCH FEEDBACK CLOSELY AND FURTHER ENHANCE QUALITY MONITORING TO ENSURE PRODUCT SAFETY AND STABILITY.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    DURING USE OF THIS PRODUCT, LEAKAGE OCCURRED FROM THE ISOLATION PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869239 INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5092938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown