BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC

    MDR report key: 23404914 · Received October 28, 2025

    Report

    Report Number
    3006948883-2025-00808
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 4, 2025
    Report Date
    February 11, 2026
    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

    CORRECTION: HEALTH EFFECT - CLINICAL CODE UPDATED FROM E2403 TO E2338 AND E2330. INVESTIGATION SUMMARY: 1. DHR/BHR REVIEW (LOT#5111369): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MAY 2025 AND PACKAGED AT R245 PACKAGE LINE IN MAY 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 4356192. REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 2 PHOTOS BUT DID NOT RETURN THE COMPLAINT UNIT. THE PHOTOS ONLY SHOW A WITHDRAWN NEEDLE CORE, WHICH APPEARS UNDAMAGED, WITH A SLIGHT DARKENING IN COLOR. 3. TAKE A RETAINED SAMPLE OF THIS BATCH FOR RELEVANT FUNCTIONAL TESTS: LIE DISTANCE, PENETRATION FORCE (INCLUDING NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE) TEST AND 45PSI LEAKAGE TEST. THE TEST RESULTS SHOW THAT THEY ALL MEET THE PRODUCT SPECIFICATIONS. 4. THE ABNORMALITY ON THE NEEDLE CORE SURFACE SHOWN IN THE RETURNED PHOTOS MAY BE CAUSED BY THE MANUFACTURING PROCESS OF THE RAW NEEDLE TUBES THEMSELVES OR BY COLOR DIFFERENCES PRODUCED BY LIGHTING. 5. THE OCCURRENCE OF THE COMPLAINT MAY BE RELATED TO THE QUALITY OF THE PRODUCT, AND MAY ALSO BE RELATED TO THE PATIENT'S SKIN, VEIN CONDITIONS AND PUNCTURE METHOD. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: INSERT THE NEEDLE AND CATHETER AT 15°~30° WITH THE BEVEL OF THE NEEDLE TIP UPWARDS, AND AFTER SEEING THE BLOOD RETURN, LOWER THE ANGLE TO 5°~10° AND CONTINUE TO SEND THE NEEDLE AND CATHETER, DO NOT WITHDRAW THE NEEDLE PREMATURELY, AND DO NOT MULTIPLE PUNCTURES. REPEATED PUNCTURES MAY CAUSE BLOOD VESSEL PERFORATION, LEADING TO LEAKAGE AND OTHER ADVERSE EFFECTS. 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 REGARDING THIS BATCH OF PRODUCTS. ACCORDING TO THE ANALYSIS OF THE INTIMA II PRODUCTION PROCESS, THE ABNORMALITY ON THE NEEDLE CORE SURFACE DESCRIBED IN THE COMPLAINT IS LIKELY COLOR DIFFERENCES CAUSED BY THE LUBRICATION OF THE NEEDLE TUBE UNDER LIGHT. SINCE THE COMPLAINT UNIT WAS NOT RECEIVED FOR FURTHER ANALYSIS, THE ROOT CAUSE OF THE REPORTED DEFECTS COULD NOT BE DETERMINED. THE PLANT WILL CONTINUE TO MONITOR THE DEFECTS.

    Additional Manufacturer Narrative · 0

    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

    ON (B)(6) 2025, 9:07 AM PATIENT ADMITTED TO THE EMERGENCY DEPARTMENT PRESENTING WITH ¿DIZZINESS FOR 2.0 DAYS.¿ MEDICAL ORDERS WERE GIVEN FOR AN IV CATHETER INSERTION. DURING THE PROCEDURE, THE NURSE EXPERIENCED FRICTION AND DIFFICULTY ADVANCING THE CATHETER. UPON REMOVING THE NEEDLE CORE FOR INSPECTION, A PARTIALLY DAMAGED AND DISCOLORED CORE WAS OBSERVED. FOLLOWING INFUSION, LEAKAGE WAS DETECTED. THE PATIENT REPORTED SIGNIFICANT PAIN. WITH MARKED SWELLING AT THE INFUSION SITE. AFTER REASSURING THE PATIENT, THE PROCEDURE WAS REPEATED. THE PATIENT CURRENTLY REPORTS NO DISCOMFORT AND REMAINS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218339 INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5111369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown