BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22666187 · Received July 30, 2025

    Report

    Report Number
    3006948883-2025-00345
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 6, 2025
    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#4052074): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MAR 2024 AND PACKAGED AT CFS PACKAGE LINE IN MAR 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. 2. THE CUSTOMER RETURNED PHOTOS BUT DID NOT RETURN THE DEFECTIVE SAMPLE. A PHOTO SHOWS THAT THE UNIT PACKAGING IS NOT OPENED, THE GAUGE IS 24G AND THE BATCH CODE IS 4052074, THERE ARE BLACK FOREIGN MATTER ATTACHED TO THE LATEX CLOSURE OF THE PRN. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTERS ARE FOUND AT THE PRN. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES. THE RETURNED PHOTO SHOWS THAT THERE IS BLACK FOREIGN MATTER ON THE PRN, BUT AS THE DEFECTIVE SAMPLE IS NOT RECEIVED FOR FURTHER TESTING, THE COMPOSITION OF THE FOREIGN MATTER CANNOT BE DETERMINED, SO THE SPECIFIC SOURCE OF THE FOREIGN MATTER CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND MONITOR SUCH DEFECTS.

    Additional Manufacturer Narrative · 0

    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 INTIMA-II Y 24GAX0.75IN PRN/EC SLM HAD FOREIGN MATTER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514911 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown