BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20676281 · Received November 13, 2024

    Report

    Report Number
    3002601200-2024-00613
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 23, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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 SAMPLES. THE PHOTO SHOWED BLOOD OOZING FROM THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#4081458. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN (B)(6) 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 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. 3. CAUSE INVESTIGATION: 1-2PCS 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. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PRODUCT MANUFACTURING PROCESS, ALL THE TEST RESULTS WERE WITHIN THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS. THE RETURNED PHOTO SHOWED BLOOD OOZING FROM THE END OF THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKAGE AT SEPTUM. THERE WAS BLOOD SEEPAGE FROM THE ISOLATION PLUG AFTER THE PUNCTURE WAS COMPLETED; THE SAMPLE COULD NOT BE RETURNED AND A PHOTO IS PROVIDED; A GREEN CLAIM IS REQUIRED; A COMPLAINT RESPONSE LETTER IS REQUIRED, BUT A RECEIPT IS NOT REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481522 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081458 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown