BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 22828072 · Received August 18, 2025

    Report

    Report Number
    3006948883-2025-00488
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 26, 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. CUSTOMER HAS NOT RETURNED SAMPLE, AND RETURNED 1 PHOTO, WHICH SHOWS THAT THE PACKAGE HAS BEEN OPENED, AND THE PRODUCT SPECIFICATION IS 24GA, THE PHOTOGRAPH SHOWS LIMITED INFORMATION, AND COMPLAINT DEFECTS ARE NOT SHOWN. 2. DHR/BHR REVIEW (LOT#4171721): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JUL 2024 AND PACKAGED AT R240 PACKAGE LINE IN JUL 2024. BATCH SIZE WAS 198,000 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. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS: NO COMPLAINTS OR DEFECTS WERE FOUND DURING THE APPEARANCE INSPECTION; 45PSI LEAKAGE TEST, NO LEAKAGE WAS OBSERVED IN THE SAMPLE. 4. GRIPPING JAWS IN THE PROCESS OF PRODUCT ASSEMBLY, IRREGULAR LOOSENING OF NEEDLE CORE AND REPEATED PUNCTURE DURING THE USE OF THE PRODUCT, WILL CAUSE DAMAGE TO THE CATHETER WALL. 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 SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR RELEVANT TESTS, AND THE USAGE OF THE SAMPLE IS UNKNOWN, AND THE STATE OF THE CATHETER RUPTURE IN THE RETURNED PHOTO IS UNIDENTIFIABLE, SO THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS 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 A-EVA-AI1-SM1-- INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC - CATHETER BROKE AFTER PLACEMENT. ON (B)(6) 2025, A PATIENT WITH HYPERTENSION WAS RECEIVING INTRAVENOUS INFUSION VIA AN INDWELLING NEEDLE WHEN A RUPTURE WAS DISCOVERED AT THE NEEDLE TIP OF THE INDWELLING NEEDLE TUBING, ACCOMPANIED BY FLUID LEAKAGE. THE DAMAGED INDWELLING NEEDLE WAS IMMEDIATELY REMOVED, A NEW PUNCTURE SITE WAS SELECTED, AND A NEW NEEDLE WAS SUCCESSFULLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762588 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4171721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown