BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 23404563 · Received October 28, 2025

    Report

    Report Number
    3006948883-2025-00805
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 18, 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

    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#5093664): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APR 2025 AND PACKAGED AT R240 & CFS PACKAGE LINE IN APR 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 BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4324289 AND 4333346. REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 3 SAMPLES AND 1 VIDEO: 1) THE VIDEO SHOWS ONE WITHDRAWN NEEDLE CORE, AND THE GROOVE OF THE NEEDLE CORE IS BLACK. 2) THE RETURNED SAMPLES SHOW THAT THE UNIT PACKAGE OF ONE SAMPLE HAS BEEN OPENED, WHILE THE UNIT PACKAGES OF THE OTHER TWO SAMPLES REMAIN UNOPENED. THE SKU IS 383078, AND THE BATCH NUMBER IS 5093664. 3) THE NEEDLE CORES OF THE RETURNED SAMPLES WERE EXAMINED UNDER A MICROSCOPE AND COMPARED WITH THE NEEDLE CORES OF THE RETAINED SAMPLES. NO DEFECTS OR ABNORMALITIES RELATED TO THE COMPLAINT WERE FOUND. 3. TAKE THE RETAINED SAMPLES FROM THE COMPLAINED BATCH FOR VISUAL INSPECTION. NO BLACKENING OR OTHER ABNORMALITIES WERE FOUND ON THE NEEDLE CORES. 4. CAUSE ANALYSIS: 1) THE NEEDLE CORE IS MADE OF 304 STAINLESS STEEL, 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 VIDEO SHOWS BLACKENING AT THE GROOVE OF THE NEEDLE CORE. THE POSSIBLE CAUSE MAY BE RELATED TO THE MANUFACTURING PROCESS OF THE RAW NEEDLE TUBE OR COLOR VARIATION CAUSED BY LIGHTING CONDITIONS. 3) NO ABNORMALITIES WERE FOUND ON THE SURFACE OF THE NEEDLE CORES IN THE RETURNED SAMPLES; THE NEEDLE TUBES ONLY APPEAR SLIGHTLY SHINY. ACCORDING TO THE ANALYSIS OF THE INTIMA II PRODUCTION PROCESS, THE REASON MAY BE THAT AFTER THE NEEDLE TUBE WAS LUBRICATED (INTIMA II PRODUCTS USE 1502C LUBRICATING FLUID FOR NEEDLE TUBE LUBRICATION, FORMING A DENSE LAYER ON THE SURFACE OF THE NEEDLE TUBE TO FACILITATE PUNCTURE), A COLOR DIFFERENCE APPEARS UNDER THE REFLECTION OF LIGHT. 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 SAMPLES WERE INSPECTED, AND NO ABNORMALITIES WERE FOUND. ACCORDING TO THE INTIMA II PRODUCTION PROCESS ANALYSIS, THE BLACKENING DESCRIBED ON THE SURFACE OF THE NEEDLE CORE IS LIKELY DUE TO COLOR VARIATION CAUSED BY THE LUBRICATING FLUID OF THE NEEDLE TUBE UNDER LIGHTING CONDITIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, MEDICAL STAFF ADMINISTERED INTRAVENOUS FLUIDS TO A PATIENT USING THIS INDWELLING NEEDLE. AFTER WITHDRAWING THE NEEDLE CORE, THE PATIENT'S FAMILY NOTICED A BLACK MARK ON THE TIP OF THE CORE. THEY IMMEDIATELY REMOVED THE INDWELLING NEEDLE AND REPLACED IT WITH A NEW ONE TO COMPLETE THE TREATMENT. THIS INCIDENT INCREASED THE PATIENT'S RISK OF INFECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029060 INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5093664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown