BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC

    MDR report key: 22437825 · Received July 8, 2025

    Report

    Report Number
    3006948883-2025-00273
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 5, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BD SUZHOU (MDS)
    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

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

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW(LOT#4233782): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN SEP 2024, AND PACKAGED AT CFS PACKAGE LINE IN SEP 2024. 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) PCS IN PROCESS TESTING AND 32PCS 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. 2. THE CUSTOMER RETURNED 2 PHOTOS, BUT DID NOT RETURN THE DEFECTIVE SAMPLES. THE PHOTOS SHOWED THAT THE SKU IS 383055,AND BLOOD OOZING FROM THE END OF THE SEPTUM. 3. PERFORMED SEPTUM LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH. THE TEST RESULT SHOWED THAT NO LEAKAGE WAS FOUND AT THE SEPTUM. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS.THE RETURNED PHOTOS SHOWS BLEEDING AT THE END OF THE ISOLATION PLUG,BUT NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED, SO THE ROOT CAUSE OF SEPTUM LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC LEAKAGE AT SEPTUM THE PATIENT WAS GIVEN AN INDWELLING SUPERFICIAL VENOUS INDWELLING NEEDLE BEFORE THE OPERATION, AND AFTER THE INDWELLING NEEDLE ENTERED THE BLOOD VESSEL, THE BLOOD RETURN IN THE BLOOD RETURN CAVITY WAS GOOD, BUT AFTER EXITING THE OCCIPITAL CORE, THE BLOOD FLOWED OUT FROM THE NEEDLE SEAT, AND THE NEEDLE WAS IMMEDIATELY REMOVED AND THE SUPERFICIAL VEIN INDWELLING NEEDLE WAS RE-INSTILLED, AND THE INFUSION WAS NORMAL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857107 BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown