BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24071618 · Received January 14, 2026

    Report

    Report Number
    3006948883-2025-01005
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 8, 2025
    Report Date
    March 6, 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. DHR/BHR REVIEW (LOT #5093670): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APR 2025, AND PACKAGED AT R240 PACKAGE LINE IN APR 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 800PCS 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. 2. THE CUSTOMER RETURNED ONE PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS BLOOD LEAKAGE AT THE END OF THE SEPTUM. 3. RETAINED SAMPLES OF THIS BATCH WERE TAKEN FOR RELATED TEST: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST RESULTS SHOWED THAT NO LEAKAGE WAS FOUND AT THE SEPTUM. 4. POSSIBLE CAUSES: 1)AFTER THE NEEDLE IS PIERCED INTO THE VEIN, THERE IS BLOOD AT THE NOTCH OF THE NEEDLE. IN THE PROCESS OF NEEDLE REMOVAL, ALTHOUGH THE PERFORATION OF THE SEPTUM IS CLOSED, THE BLOOD DROPS IN THE NOTCH WILL BE BROUGHT OUT WITH THE NOTCH. IF THERE IS A LOT OF INERTIA IN THE NEEDLE REMOVAL PROCESS, BLOOD DROPS WILL BE THROWN OUT. 2)IF THE PATIENT'S ARM IS TIED TIGHT DURING THE PUNCTURE, IT WILL CAUSE GREAT PRESSURE IN THE VEIN, AND BLOOD WILL COME OUT WITH THE NEEDLE WHEN THE NEEDLE IS PULLED OUT, BUT THE SUBSEQUENT BLOOD LEAKAGE WILL NOT BE SUSTAINED. 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 ABOUT THIS BATCH OF PRODUCTS. THE RETURNED PHOTO SHOWS BLOOD SEEPAGE AT THE END OF THE SEPTUM, AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED, SO THE ROOT CAUSE OF THE COMPLAINT DEFECT CANNOT BE DETERMINED. 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 AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED ON (B)(6) 2025, THE PEDIATRIC PATIENT PRESENTED TO THE (B)(6) DEPARTMENT WITH A 3-DAY HISTORY OF FEVER AND WAS DIAGNOSED WITH ACUTE UPPER RESPIRATORY TRACT INFECTION. THE PHYSICIAN PRESCRIBED PARAMILVIR INJECTION FOR INTRAVENOUS INFUSION AT THE (B)(6). AT 17:25, A CLOSED-SYSTEM INTRAVENOUS CATHETER WAS INSERTED IN THE TREATMENT ROOM. IMMEDIATELY AFTER INSERTION, THE NURSE OBSERVED BLOOD LEAKING FROM THE WHITE BASE OF THE CATHETER AND PROMPTLY REPLACED IT WITH A NEW CATHETER FOR REINSERTION. THE SECOND INSERTION CAUSED VASCULAR DAMAGE AND DISCOMFORT TO THE PATIENT, WHILE ALSO INCREASING THE NURSE'S WORKLOAD AND STRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134279 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 5093670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown