BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21138635 · Received January 13, 2025

    Report

    Report Number
    3002601200-2024-00813
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830626
    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. DHR/BHR REVIEW LOT # 4052078. 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 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. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR FUNCTIONAL TESTING: 45PSI LEAKAGE TEST, AND NO LEAKAGE OR OTHER ABNORMALITIES ARE FOUND AT THE PRN AND THE END CAP. 4. SKU # 383062 IS A PRODUCT WITH Y PP CONNECTOR, WHICH HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE PRODUCT OF THIS SKU HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE PRN OR THE END CAP FALLING OFF MAY BE RELATED TO THE WRONG USE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC LEAKAGE WITH POWER INJECTOR. WHEN THE PATIENT DID CTA EXAMINATION, HIGH PRESSURE INJECTION OF CONTRAST MEDIUM, THE CAP OF THE INDWELLING NEEDLE SECTION FELL OFF, AND THE PATIENT'S BLOOD AND CONTRAST MEDIUM FLOWED OUT IN TIME TO STOP THE BLEEDING OF THE PATIENT, REPLACED WITH A NEW PRODUCT, AND IT WAS USED NORMALLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499697 BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052078 00382903830626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown