BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 23647180 · Received November 25, 2025

    Report

    Report Number
    3006948883-2025-00902
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 15, 2025
    Report Date
    January 2, 2026
    Manufacturer
    BD SUZHOU (MDS)
    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 PROVIDED 1 VIDEO AND RETURNED THE COMPLAINT UNIT: 1) THE VIDEO SHOWS: THE EXTENSION TUBE NEAR THE PP CONNECTOR END IS LEAKING. 2) THE RETURNED COMPLAINT UNIT SHOWS: THE PART NUMBER IS 383078, BATCH NUMBER IS 5093664. THERE IS DAMAGE ON THE EXTENSION TUBE ABOUT 5MM FROM THE PP CONNECTOR, CAUSING LEAKAGE. 2. 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 EXTENSION TUBING BATCH USED IN THIS BATCH OF PRODUCTS IS 5052409. REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. FUNCTIONAL TESTING (45PSI LEAKAGE TEST) WAS PERFORMED ON A RETAINED SAMPLE OF THE COMPLAINT BATCH, THE RESULT IS QUALIFIED, NO LEAKAGE WAS FOUND IN ANY PART OF THE TESTED SAMPLE. 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. AT THE SAME TIME, AFTER THE OPERATOR ANNOUNCES THE PIN REPLACEMENT, ATTENTION SHOULD BE PAID TO THE PRODUCT QUALITY DURING THIS PERIOD. 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 COMPLAINT UNIT, IT WAS CONCLUDED THAT 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

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672310 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 5093664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown