BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23839551 · Received December 18, 2025

    Report

    Report Number
    3006948883-2025-00950
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    December 3, 2025
    Report Date
    February 5, 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 RETURNED ONE PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE SPECIFICATION IS 24G, AND THERE IS BLOOD SEEPING ON THE EXTENSION TUBE OF THE SAMPLE, BUT THE EXACT POINT OF LEAKAGE CANNOT BE IDENTIFIED. 2. DHR/BHR REVIEW (LOT#4233778): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN AUG 2024 AND PACKAGED AT CFS PACKAGE LINE IN AUG 2024. 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. 3. LEAKAGE TESTS WAS DONE ON THE RETAINED SAMPLE OF THIS BATCH, THE TEST IS QUALIFIED, NO LEAKAGE AT THE EXTENSION TUBING. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. THE RETURNED PHOTO SHOWS BLOOD LEAKAGE AT THE EXTENSION TUBE, BUT THE SPECIFIC LOCATION OF THE LEAK CANNOT BE IDENTIFIED FROM THE PHOTO, AND THE ABNORMAL CONDITION OF THE EXTENSION TUBE IS UNCLEAR. ADDITIONALLY, NO DEFECTIVE SAMPLES WERE RECEIVED FOR FURTHER ANALYSIS, THE ROOT CAUSE OF THE LEAKAGE IN THE EXTENSION TUBE 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 LEAKAGE AT ADAPTER TUBING JUNCTION DURING USE, LEAKAGE WAS DISCOVERED IN THE EXTENSION TUBE. ONE DEFECTIVE UNIT WAS IDENTIFIED, AND THE FAULTY PRODUCT CANNOT BE RETURNED. PHOTOGRAPHIC EVIDENCE IS AVAILABLE. A CLAIM IS REQUIRED, ALONG WITH A FORMAL COMPLAINT RESPONSE LETTER AND A COMPLAINT ACKNOWLEDGEMENT LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251525 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown