BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 22396240 · Received July 3, 2025

    Report

    Report Number
    3006948883-2025-00264
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 30, 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 1 PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWED BLOOD OOZING FROM THE END OF THE SEPTUM. 2. DHR/BHR REVIEW(LOT # 4052079): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. 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 (B)(4) PCS IN PROCESS TESTING AND (B)(4) PCS 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. CAUSE INVESTIGATION: 1) 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. PLEASE REFER TO THE ATTACHMENT FOR THE TEST REPORTS. 2) THE PLANT HAS LAUNCHED CAPA TO FURTHER INVESTIGATE THE ROOT CAUSE, CAPA # 10977167. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PRODUCTION PROCESS, ALL THE TEST RESULTS WERE WITHIN THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS. THE RETURNED PHOTOS SHOWED THE LEAKAGE SITE WAS AT THE END OF THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE, CAPA # 10977167.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED WHEN REMOVING THE NEEDLE CONE, BLOOD LEAKED FROM THE ISOLATION PLUG. NO CLAIM IS NECESSARY, BUT A COMPLAINT RESPONSE LETTER AND COMPLAINT RECEIPT LETTER ARE REQUIRED. DEFECTIVE PRODUCT CANNOT BE RETURNED, BUT PHOTOS ARE AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845047 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown