BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20712441 · Received November 18, 2024

    Report

    Report Number
    3002601200-2024-00628
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 24, 2024
    Report Date
    January 13, 2025
    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

    1. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW LOT#4198428 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUGUST 2024, AND PACKAGED AT R240 PACKAGE LINE IN AUGUST 2024. WORK ORDER QUANTITY WAS (B)(6) 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. DHR/BHR REVIEW LOT#4081456 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS 198,000 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. 4. TWO BATCHES OF RETAINED SAMPLES (LOT#4198428 & LOT#408145) ARE TAKEN FOR 800MM SIMULATED CLINICAL LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE SEPTA. CONCLUSION(S): THE ROOT CAUSE OF THE LEAKAGE AT THE SEPTUM CANNOT BE DETERMINED BECAUSE THERE ARE NO ABNORMALITIES IN THE MANUFACTURING PROCESS AND RETAINED SAMPLES OF THE TWO BATCHES 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

    1. DHR/BHR REVIEW LOT#4198428 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUGUST 2024, AND PACKAGED AT R240 PACKAGE LINE IN AUGUST 2024. WORK ORDER QUANTITY WAS 198,000 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. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE SPECIFIC LEAKAGE SITE AND ABNORMAL STATES OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED.

    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

    ADDITIONAL INFORMATION PROVIDED. AFTER THE CLIENT'S PUNCTURE WAS SUCCESSFUL, THE BLOOD LEAKED DIRECTLY FROM THE ISOLATION PLUG AND THE LOT CODE WAS 4081456THERE ARE NO PICTURES AND VIDEOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKAGE ON (B)(6) 2024 AFTER PLACING AN INDWELLING NEEDLE FOR A PATIENT THE STEEL NEEDLE WITHDREW AND BLOOD FOLLOWED, A RESET OF THE INDWELLING NEEDLE WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604225 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4198428 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown