BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21921067 · Received April 28, 2025

    Report

    Report Number
    3006948883-2025-00105
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 21, 2025
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER DIDN¿T RETURN PHOTOS AND DEFECTIVE SAMPLE. 2. DHR/BHR REVIEW (LOT#3234067): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUG 2023 AND PACKAGED AT R240 PACKAGE LINE IN SEP 2023. 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. FUNCTIONAL TEST (45PSI LEAKAGE TEST) IS CONDUCTED ON THE RETAINED SAMPLE OF THE COMPLAINED BATCH, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE SEPTUM. 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 DEFECTIVE PRODUCTS. THE VISUAL INSPECTION SYSTEM IS CHALLENGED WITH STANDARD SAMPLES EVERY 12 HOURS AND WHEN CHANGING PRODUCT GAUGE TO ENSURE THE EFFECTIVENESS OF THE INSPECTION. 5. THE PRODUCT (SKU#383057) WHICH HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, IT IS RECOMMENDED CUSTOMERS TO USE THE APPROPRIATE PRODUCT FOR HIGH-PRESSURE INJECTION. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. AS THIS PRODUCT (SKU 383057) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE SEPTUM IS FLUSHED OFF CANNOT BE CONFIRMED TO BE RELATED TO THE PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM NPVC LEAKED WITH POWER INJECTOR DURING THE HIGH-PRESSURE INJECTION PROCESS, THE ISOLATION PLUG FELL OFF. A CLAIM IS REQUIRED, A COMPLAINT REPLY LETTER IS REQUIRED, AND A COMPLAINT RECEIPT LETTER IS NOT REQUIRED. ONE DEFECTIVE PRODUCT CAN BE RETURNED WITH PHOTOS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223001 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3234067 00382903830572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown