BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23370865 · Received October 23, 2025

    Report

    Report Number
    3006948883-2025-00795
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 5, 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 PHOTO AND 1 DEFECTIVE SAMPLE: 1) THE PHOTO SHOWS THAT THE SKU IS 383033. THE SAMPLE HAS BEEN USED, AND THE EXTENSION TUBE OF THE SAMPLE (NEAR THE PP CONNECTOR END) HAS BLOOD SEEPAGE. 2) THE RETURNED SAMPLE SHOWS: THE SPECIFICATION IS 24G, AND THERE IS BLOOD IN THE SAMPLE'S EXTENSION TUBE. MICROSCOPE EXAMINATION OF THE SAMPLE'S EXTENSION TUBE REVEALED DAMAGE ON THE TUBE, WHICH IS APPROXIMATELY 2MM FROM THE METAL WEDGE INSIDE THE PP CONNECTOR. 2. DHR/BHR REVIEW (LOT#5048547): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAR 2025 AND PACKAGED AT R240 PACKAGE LINE IN MAR 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 EXTENSION TUBING BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4358977 AND 5010813. REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST. THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 4. POSSIBLE CAUSE: 1) BASED ON THE ANALYSIS OF THE DAMAGED AREA AND CONDITION OF THE RETURNED SAMPLE EXTENSION TUBE, THE EXTENSION TUBE WAS PIERCED BY THE TURNTABLE PIN OF Z6 DURING THE ASSEMBLY OF THE INDWELLING NEEDLE. 2) AFTER THE Z6 TURNTABLE PIN BREAKS, IT IS REPLACED BY THE OPERATOR. SOMETIMES THE REPLACED PIN HAS BURRS, WHICH CAN CAUSE DAMAGE TO THE EXTENSION TUBE AT THE Z6S11 AND S12 PUNCHING STATIONS. 5. IMPROVEMENT MEASURES TAKEN: AFTER REPLACING WITH A NEW PIN, INSPECT THE PIN UNDER A MICROSCOPE TO ENSURE THAT THE REPLACED PIN HAS NO BURRS OR OTHER ABNORMALITIES, THEREBY ENSURING QUALITY. 6. 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. AFTER THE INSPECTION OF THE RETURNED SAMPLE, THE EXTENSION TUBE WAS DAMAGED DUE TO BEING PIERCED BY THE TURNTABLE PIN OF Z6 DURING THE ASSEMBLY OF THE INDWELLING NEEDLE. THE PLANT HAS TAKEN CORRECTIVE ACTIONS AND WILL CONTINUOUSLY MONITOR THIS DEFECT ISSUE.

    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 IS AVAILABLE.

    Description of Event or Problem · 0

    DURING USE, THIS PRODUCT HAS EXPERIENCED LEAKAGE/BLEEDING AT THE CONNECTION BETWEEN THE EXTENSION TUBE AND THE NEEDLE HUB. ONE NEEDLE IS AFFECTED. A SAMPLE CAN BE RETURNED, AND PHOTOS ARE AVAILABLE. A COMPLAINT RESPONSE LETTER IS REQUIRED (BECAUSE THIS OCCURRED IN A CHILD, THE FAMILY AND HOSPITAL ARE EXTREMELY CONCERNED, AND WE WOULD APPRECIATE A PROMPT RESPONSE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729906 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5048547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown