BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 21200373 · Received January 21, 2025

    Report

    Report Number
    3002601200-2024-00829
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 27, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830572
    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 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE SEPTUM OF THE SAMPLE HAS FALLEN OFF. 2. DHR/BHR REVIEW LOT# 4052076 1 THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS(B)(4)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. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTING: 45PSI LEAKAGE TEST, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE SEPTUM. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. THE SEPTUM AND THE CATHETER HUB ARE BONDED BY UV ADHESIVE. AFTER THE ADHESIVE IS DRIED, THE VISUAL INSPECTION SYSTEM CONDUCTS 100% INSPECTION, WHICH WILL AUTOMATICALLY IDENTIFY AND REMOVE THE DEFECTIVE PRODUCT. THE VISUAL INSPECTION SYSTEM IS CHALLENGED WITH STANDARD SAMPLES EVERY DAY AT 7:00, 19:00 AND WHEN CHANGING PRODUCT GAUGE TO ENSURE THE EFFECTIVENESS OF THE INSPECTION. 5. THE PRODUCT SKU 383057 HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. CONCLUSION THE RETURNED PHOTO SHOWS THAT THE SEPTUM OF THE SAMPLE HAS FALLEN OFF, THE ROOT CAUSE OF THIS DEFECT CANNOT BE CONFIRMED BECAUSE THERE ARE NO ABNORMALITIES IN THE PRODUCTION PROCESS AND RETAINED SAMPLE, THE PRODUCT OF THIS SKU HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, THE DEFECTIVE SAMPLE IS NOT RECEIVED, AND THE FLOW RATE AND PRESSURE USED WHEN INJECTING THE CONTRAST AGENT ARE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM NPVC LEAKED WITH POWER INJECTION THE OUTPATIENT IMAGING DEPARTMENT REPORTED THAT DURING THE PROCESS OF ENTERING THE CONTRAST AGENT, THE INDWELLING NEEDLE BURST TUBE STOPPER POPPED OUT, AND THE AFFECTED QUANTITY WAS 1 TUBE. THE SAMPLE CANNOT BE RETURNED, BUT PHOTOS CAN BE PROVIDED. A GREEN CLAIM SETTLEMENT IS REQUIRED, AS WELL AS A COMPLAINT RESPONSE LETTER AND A COMPLAINT ACCEPTANCE LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722486 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052076 00382903830572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown