BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 19661115 · Received July 2, 2024

    Report

    Report Number
    3002601200-2024-00284
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 15, 2024
    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

    1. THE CUSTOMER RETURNED 3 ACTUAL SAMPLES, THE SKU IS 383083, THE BATCH CODE IS 3171582, AMONG WHICH 2 SAMPLES ARE FOUND TO BE NORMAL, AND 1 SAMPLE HAS A BLACK DOT AT THE PP CONNECTOR. PLEASE SEE ATTACHMENT PR#(B)(4)-1 FOR PHOTOS. 2. DHR/BHR REVIEW (LOT#3171582): 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2023, AND PACKAGED AT R240 PACKAGE LINE IN JULY 2023. WORK ORDER QUANTITY WAS (B)(4) EA. 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. NO SAME DEFECT IS FOUND IN THE RETAINED SAMPLES OF THE COMPLAINED BATCH. PLEASE SEE ATTACHMENT PR# (B)(4) FOR THE INSPECTION REPORT. 4. AFTER INSPECTION AND ANALYSIS BY THE PP CONNECTOR MANUFACTURING ENGINEER, IT IS DETERMINED THAT THE BLACK DOT IS NOT DIRTY, BUT THE MOLDING DEFECT OF THE PP CONNECTOR. BECAUSE THE SEALING RING OF THE HOT RUNNER CYLINDER IS DAMAGED, THE AIR LEAKAGE CAUSES INSUFFICIENT AIR PRESSURE TO COMPLETELY DRIVE THE VALVE PIN IN PLACE, CAUSING THE VALVE PIN TO STICK MATERIAL, AND INSUFFICIENT MATERIAL TO ENTER THE MOLD CAVITY, RESULTING IN THE BLACK DOT AT THE PP CONNECTOR. 5. ACTIONS TAKEN: REPLACE THE SEALING RING OF THE HOT RUNNER CYLINDER EVERY 6 MONTHS AND MODIFY THE DOCUMENT MFG-0038-K, SCHEDULED TO BE COMPLETED BY THE END OF JULY 2024. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION: NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THROUGH THE INSPECTION AND ANALYSIS OF THE DEFECTIVE SAMPLE, IT IS CONFIRMED THAT THE BLACK DOT AT THE PP CONNECTOR IS A MOLDING DEFECT CAUSED BY THE DAMAGE OF THE HOT RUNNER CYLINDER SEAL RING. THE PLANT HAS PLANNED TO COMPLETE THE IMPROVEMENT ACTIONS AT THE END OF JULY 2024.

    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 INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC HAD FOREIGN MATTER. WHEN USING INDWELLING NEEDLES IN THE RHEUMATOLOGY AND IMMUNOLOGY DEPARTMENT OF SHENZHEN THIRD PEOPLE'S HOSPITAL, BLACK FOREIGN MATTER WAS FOUND ON THE SURFACE OF THE Y-TYPE LUER INTERFACE AND COULD NOT BE REMOVED, THE NUMBER OF AFFECTED UNITS WAS 1, AND THE RELEVANT INFORMATION OF THE MEDICAL STAFF COULD NOT BE PROVIDED, THE HOSPITAL REPORTED THE COMPLAINT TO THE DISTRIBUTOR, AND THEN THE DISTRIBUTOR REPORTED IT TO THE BD SALES STAFF, THE SAMPLES CAN BE RETURNED, AND THE PHOTOGRAPHS CAN BE PROVIDED, AND IT NEEDS TO BE A GREEN CLAIM, AND IT NEEDS TO BE A LETTER OF REPLY TO AND ACCEPTANCE OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507823 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3171582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown