BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 22GAX1.00IN PRN SLM NPVC HP

    MDR report key: 23524447 · Received November 11, 2025

    Report

    Report Number
    3006948883-2025-00858
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    November 3, 2025
    Report Date
    February 1, 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

    1.THE CUSTOMER RETURNED 1 VIDEO AND 1 USED SAMPLE. 1)THE RETURNED VIDEO SHOWS THAT THE SEPTUM OF THE SAMPLE HAS BEEN DISLODGED CAUSED TO LEAKAGE. 2)THE RETURN SAMPLE SHOWS THAT THE SEPTUM HAS MOVED. 3)CHECK THE DISTRIBUTION OF UV ADHESIVE IN THE CATHETER HUB OF THE RETURNED SAMPLE UNDER THE PURPLE LAMP. NO ABNORMALITY IS FOUND IN THE AMOUNT AND DISTRIBUTION OF UV ADHESIVE. 2. DHR/BHR REVIEW (LOT 5093665): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2025 AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2025. WORK ORDER QUANTITY WAS (B)(4) PCS. 2)THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3)THE LEAKAGE TEST RESULTS OF 160PCS IN PROCESS TESTING AND 32PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS. 4)NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS. 5)THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST. THE TESTS ARE PASSED, AND NO LEAKAGE IS FOUND AT THE SEPTUM AND OTHER PARTS OF THE SAMPLE. 4. CAUSE ANALYSIS: 1)BASED ON THE SAMPLE ANALYSIS RESULTS, THE LEAKAGE OCCURRED DUE TO DISPLACEMENT OF THE ISOLATING PLUG. THE DISPLACEMENT OF THE ISOLATING PLUG MAY BE CAUSED BY VARIOUS FACTORS: THE OUTER DIAMETER OF THE ISOLATING PLUG, THE INNER DIAMETER OF THE CATHETER SEAT, INSUFFICIENT ADHESIVE APPLIED TO THE ISOLATING PLUG, CONTAMINATION OF THE ISOLATING PLUG WITH LUBRICANT(A SOLVENT CONTAINING MEDICAL-GRADE SILICONE OIL), AND VARIATIONS IN THE RAW MATERIAL OF THE ISOLATING PLUG -ALL OF WHICH CAN AFFECT THE SEALING PERFORMANCE OF THE PRODUCT. 2)BASED ON THE RETURNED SAMPLE ANALYSIS RESULTS AND THE INFORMATION PROVIDED BY THE CUSTOMER, IT HAS BEEN CONFIRMED THAT THE OUTER DIAMETER OF THE ISOLATING PLUG, THE INNER DIAMETER OF THE CATHETER SEAT, AND THE ADHESIVE APPLIED TO THE ISOLATING PLUG ARE ALL WITHIN NORMAL PARAMETERS. THE ISSUE MAY HAVE OCCURRED DURING THE SYRINGE LUBRICATION PROCESS, WHERE THE ISOLATING PLUG WAS CONTAMINATED WITH A SMALL AMOUNT OF RESIDUAL LUBRICANT (A SOLVENT CONTAINING MEDICAL-GRADE SILICONE OIL). THIS CONTAMINATION COULD HAVE COMPROMISED THE BONDING BETWEEN THE ISOLATING PLUG AND THE CATHETER SEAT, RESULTING IN THE PRODUCT¿S INABILITY TO MAINTAIN A SEALED CONDITION UNDER SUSTAINED HIGH-PRESSURE, WHICH ULTIMATELY LED TO LEAKAGE. 5. THE PLANT HAS IMMEDIATELY IMPLEMENTED CORRESPONDING CORRECTIVE ACTIONS TO ADDRESS THE POTENTIAL CAUSES OF THIS DEFECT: 1)CLEAN THE AIR-BLOWING GROOVES AND OPTIMIZE THE POSITION OF THE ISOLATING PLUG DURING NEEDLE LUBRICATION. 2)OPTIMIZE THE SIZE OF THE LUBRICATION GROOVE TO PREVENT THE ISOLATING PLUG FROM COMING INTO DIRECT CONTACT WITH THE LUBRICANT, ENSURING PROPER BONDING BETWEEN THE ISOLATING PLUG AND THE CATHETER SEAT TO IMPROVE THE PRODUCT¿S SEALING QUALITY. THE EFFECTIVENESS OF THESE IMPROVEMENT MEASURES IS CURRENTLY BEING MONITORED. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BASED ON THE ANALYSIS OF THE RETURNED SAMPLES AND THE INFORMATION PROVIDED BY THE CUSTOMER, IT IS SUSPECTED THAT THE ISOLATING PLUG WAS CONTAMINATED WITH A SMALL AMOUNT OF RESIDUAL LUBRICANT, WHICH COMPROMISED THE PRODUCT¿S SEALING PERFORMANCE AND RESULTED IN ITS INABILITY TO MAINTAIN INTEGRITY UNDER HIGH-PRESSURE CONDITIONS. THIS PHENOMENON IS CONSIDERED A LOW-PROBABILITY EVENT. THE PLANT HAS CONDUCTED A COMPREHENSIVE EVALUATION OF THE RELEVANT PRODUCTION PROCESSES THAT COULD LEAD TO THIS DEFECT AND HAS IMPLEMENTED CORRECTIVE MEASURES. CONTINUOUS MONITORING OF THE DEFECT COMPLAINT TREND WILL BE CARRIED OUT.

    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 AVAILABLE.

    Description of Event or Problem · 0

    ON THE MORNING ON (B)(6) 2025, DURING AN ABDOMINAL CONTRAST-ENHANCED CT SCAN, THE UPPER SECTION OF THE WHITE ISOLATION CAP ON THE INDWELLING NEEDLE RUPTURED AND LEAKED CONTRAST AGENT WHILE THE MICRO-PUMP WAS ADMINISTERING HIGH-PRESSURE CONTRAST INJECTION. THE CATHETER WAS IMMEDIATELY REMOVED AND REINSERTED, AFTER WHICH CONTRAST INJECTION PROCEEDED SMOOTHLY, AND THE EXAMINATION WAS COMPLETED SAFELY. THIS REINSERTION CAUSED ADDITIONAL DISCOMFORT TO THE PATIENT, RESULTED IN WASTE OF MEDICATION, AND DELAYED THE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645904 INTIMA-II 22GAX1.00IN PRN SLM NPVC HP INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5093665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown