BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM

    MDR report key: 20793109 · Received November 27, 2024

    Report

    Report Number
    3002601200-2024-00657
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 12, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830077
    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 2 PHOTOS, BUT DID NOT RETURN THE DEFECTIVE SAMPLES. THE PHOTOS SHOW BLOOD AND FLUID OOZING FROM THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#: 4081480. 1. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT CFS 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 320 PCS IN PROCESS TESTING AND 32 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. TWO RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST. THE TEST RESULTS SHOW THAT NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHED TEST REPORTS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED PHOTOS SHOW BLOOD AND FLUID OOZING FROM THE END OF THE SEPTUM, THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED BECAUSE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLES ARE RECEIVED FOR FURTHER TESTING. THE PLANT WILL CONTINUE TO TRACK AND TREND THE 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 PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM LEAKAGE AT SEPTUM DURING USE OF THE PRODUCT, THERE WAS BLEEDING AND OOZING FROM THE ISOLATION PLUG; THE NUMBER AFFECTED WAS 3, THE SAMPLE CANNOT BE RETURNED, AND A PHOTO IS PROVIDED; A GREEN CLAIM IS REQUIRED, AND A COMPLAINT RESPONSE LETTER AND COMPLAINT ACCEPTANCE LETTER ARE NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451635 BD INTIMA-II 20GAX1.16IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081480 00382903830077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown