BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 22141796 · Received June 4, 2025

    Report

    Report Number
    3006948883-2025-00179
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 9, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830572
    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. DHR/BHR REVIEW(LOT#4171666): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN JULY 2024, AND PACKAGED AT CFS PACKAGE LINE IN JULY 2024. 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. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTERS ARE FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. AS THE STATUS AND COMPOSITION OF THE BLACK SPOT ON THE INDWELLING NEEDLE CANNOT BE CONFIRMED, SO THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO AND MONITOR SUCH DEFECTS.

    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

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM NPVC HAD FOREIGN MATTER. THE INDWELLING NEEDLE HAS A BLACK SPOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529995 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171666 00382903830572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown