BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 23512031 · Received November 10, 2025

    Report

    Report Number
    3006948883-2025-00849
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 15, 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#5126687): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2025 AND PACKAGED AT R240 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. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3) REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4) THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 5052312, 5052314 AND 5113147. REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 1 PHOTO AND 1 SAMPLE: 1) THE PHOTO SHOWS THAT BLOOD FLOWS FROM THE CLAMPED EXTENSION TUBE INTO THE HEPARIN CAP END AND LEAKS. 2) THE RETURNED SAMPLE SHOWS BLOOD BACKFLOW IN THE EXTENSION TUBE. A COMPARISON BETWEEN THE RETURNED SAMPLE AND THE RETAINED SAMPLE REVEALED THAT THE RETURNED SAMPLE HAS IMPROPER LUER ENGAGEMENT, I.E. MISALIGNMENT, BETWEEN THE PRN AND THE PP CONNECTOR. 3) INSPECTION OF THE RETURNED SAMPLE¿S CLAMP CLOSURE REVEALED THAT THE EXTENSION TUBE WAS NOT CENTERED WITHIN THE CLAMP. 3. TAKE A RETAINED SAMPLE FROM THIS BATCH FOR RELEVANT TESTING. 1) 45 PSI LEAKAGE TEST PASSED, NO LEAKAGE OBSERVED IN THE SAMPLE. 2) CLAMP FORCE TEST AND THE SEALING PRESSURE TEST OF THE PINCH CLAMP (PRESSURE UPPER LIMIT 102KPA). THE SAMPLE PASSED THE TESTS, AND THE CLAMP CAN EFFECTIVELY OCCLUDE THE EXTENSION TUBE. 4. DEFECT ANALYSIS: 1) THE CUSTOMER REPORTED ¿A GAP ON THE NEEDLE HUB CAUSING BLOOD LEAKAGE¿. AFTER ANALYSIS, THE LEAKAGE WAS DETERMINED TO BE CAUSED BY MISALIGNMENT OF THE PRN. 2) IN THE ASSEMBLY PROCESS OF PRN, THERE ARE TORQUE AND ASSEMBLY STROKE MONITORING TO ENSURE THAT THE LUER OF PRN CAN BE ASSEMBLED INTO THE PP CONNECTOR TO A CERTAIN DEPTH AND THE THREAD HAS A GOOD FASTENING EFFECT. IF THE PRN IS NOT IN PLACE, THE EQUIPMENT WILL ALARM AND REMOVE THE PRODUCT. 3) NO PREVIOUS COMPLAINTS REGARDING HEPARIN CAP MISALIGNMENT WERE RECORDED BEFORE THIS CASE, SUGGESTING THAT THE OCCURRENCE RATE OF THIS DEFECT IS EXTREMELY LOW. 5. CORRECTIVE MEASURES AND RECOMMENDATIONS: 1) ORAL TRAINING HAS BEEN PROVIDED TO THE RELEVANT OPERATORS. WHEN SUCH DEFECTS ARE FOUND DURING VISUAL INSPECTION, DEFECTIVE PRODUCTS NEED TO BE REMOVED. 2) IT IS ALSO RECOMMENDED THAT CUSTOMERS CHECK BEFORE USE AND STRAIGHTEN THE CATHETER INSIDE THE CLAMP WHILE CENTERING IT, AS THIS CAN SOLVE THE PROBLEM OF BLOOD BACKFLOW CAUSED BY THE CLAMP NOT BEING TIGHT ENOUGH. 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. THE RETURNED SAMPLE SHOWED MISALIGNMENT BETWEEN THE PRN AND THE PP CONNECTOR'S LUER LOCK. THERE ARE VARIOUS INSPECTIONS IN PLACE DURING THE PRODUCTION PROCESS. RELEVANT OPERATIONAL STAFF HAVE BEEN TRAINED TO PROMPTLY IDENTIFY AND REMOVE SUCH DEFECTS. MOREOVER, THE OCCURRENCE OF THIS COMPLAINT DEFECT IS CONSIDERED AN ISOLATED INCIDENT. THE PLANT WILL CONTINUE TO MONITOR AND CONTROL THE OCCURRENCE OF SUCH DEFECTS.

    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 INSERTION OF AN IV CATHETER INTO A PATIENT, A GAP WAS DISCOVERED ON THE NEEDLE HUB, CAUSING BLOOD LEAKAGE. THE CATHETER WAS REMOVED AND A NEW ONE WAS REINSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2524587 INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5126687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown