BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 23111833 · Received September 22, 2025

    Report

    Report Number
    3006948883-2025-00697
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 12, 2025
    Report Date
    November 11, 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. DHR/BHR REVIEW(LOT#4351728): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN JAN 2025, AND PACKAGED AT R240 PACKAGE LINE IN JAN 2025. 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. 4)THE CANNULA BATCH USED IN THIS BATCH OF PRODUCTS IS 4142435, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED A PHOTO AND DID NOT RETURN DEFECTIVE SAMPLE. THE PHOTO SHOWS A WITHDRAWN NEEDLE CORE, WITH UNEVEN COLORATION ON ITS SURFACE. 3. RETAIN SAMPLE FROM THE COMPLAINED BATCH WAS TAKEN FOR INSPECTION. UNDER THE MICROSCOPE, NO RUST WAS OBSERVED ON THE NEEDLE CORE. 4. CAUSE ANALYSIS: 1)THE NEEDLE CORE IS MADE OF 304 STAINLESS STEEL AND LUBRICATED BY SILICONE, WHICH HAS GOOD RUST RESISTANCE UNDER NORMAL CIRCUMSTANCES, BUT UNDER SPECIAL CONDITIONS (SUCH AS IN THE AIR CONTAINING CHLORINATED CHEMICALS), THE HEAD OF THE NEEDLE CORE MAY RUST. THE PLANT DOES NOT HAVE THE CONDITIONS TO CAUSE THE DEFECT IN THE PRODUCTION PROCESS. 2)THE RETURNED PHOTO SUGGESTS THAT THE ABNORMAL APPEARANCE ON THE NEEDLE TUBE SURFACE MAY NOT BE CAUSED BY RUST, BUT RATHER BY COLOR VARIATION RESULTING FROM THE MANUFACTURING PROCESS OF THE RAW MATERIAL ITSELF. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS.THE RETURNED PHOTO SHOWS THAT THE NEEDLE TUBE SURFACE HAS UNEVEN COLORATION,BUT BECAUSE DEFECTIVE SAMPLE IS NOT RECEIVED FOR FURTHER DETECTION AND ANALYSIS, SO THE ROOT CAUSE OF THE RUST OF THE NEEDLE CORE CANNOT BE DETERMINED.THE PLANT WILL CONTINUE TO MONITOR THE DEFECT.

    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 Y 20GAX1.16IN PRN/EC SLM-383012 -RUST/CORROSION. THE EMERGENCY DEPARTMENT AT THE (B)(6) MEDICINE REPORTED RUST ON STEEL NEEDLES UPON UNPACKING ON SEPTEMBER 16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526994 INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4351728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown