BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20791780 · Received November 27, 2024

    Report

    Report Number
    3002601200-2024-00665
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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#4081466 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT CFS PACKAGE LINE IN MAY 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 400PCS 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR 800MM SIMULATED CLINICAL LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE SEPTUMS. PLEASE SEE THE ATTACHED TEST REPORTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PROCESS AND RETAINED SAMPLES. SINCE THE DEFECTIVE SAMPLES ARE NOT RETURNED FOR FURTHER TESTING, THE ROOT CAUSE OF THE LEAKAGE AT THE SEPTUM CANNOT BE DETERMINED. 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 24GAX0.75IN PRN SLM NPVC LEAKAGE AT SEPTUM THE INSTRUMENT DEPARTMENT REPORTED THAT WHEN WITHDRAWING THE NEEDLE CORE AFTER PUNCTURE OF THIS PRODUCT, THERE WAS A LEAK FROM THE ISOLATION PLUG. THIS PROBLEM OCCURRED IN THE NEPHROLOGY DEPARTMENT. THE NUMBER AFFECTED WAS 4, THE SAMPLE COULD NOT BE RETURNED, AND NO PHOTOS WERE PROVIDED. NO GREEN CLAIM IS REQUIRED, NO COMPLAINT RESPONSE LETTER IS REQUIRED, AND NO COMPLAINT ACCEPTANCE LETTER IS REQUIRED. SALES SAID: IF YOU NEED TO COMMUNICATE WITH THE DIRECTOR BY PHONE AFTERWARDS, IT IS BEST TO INFORM SALES IN ADVANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826423 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081466 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown