BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II

    MDR report key: 21721845 · Received March 28, 2025

    Report

    Report Number
    3006948883-2025-00036
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 23, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830503
    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 SAMPLE RETURNED BY THE CUSTOMER WAS USED AND WAS RETURNED WITHOUT THE ORIGINAL PRODUCT PACKAGING. THE CUSTOMER PACKAGING IN WHICH THE SAMPLE WAS RETURNED SHOWS DETAILED PRODUCT INFORMATION, THE NEEDLE TUBE OF THE PRODUCT HAS BEEN REMOVED, OBVIOUS NEEDLE PENETRATION MARKS HAVE BEEN OBSERVED FROM THE TAIL OF THE PRODUCT, THE ISOLATION PLUG HAS BEEN SHIFTED, AND THE ANALYSIS FROM THIS STATE HAS BEEN USED IN HIGH-PRESSURE (CT) INJECTION SCENARIOS. OUR PRODUCT IS NOT SUITABLE FOR HIGH PRESSURE INJECTION. 2. PRODUCTION RECORD CHECK (LOT#4171135): 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN JULY 2024 AND PACKAGED IN CFS PACKAGING LINE IN JULY 2024. THE NUMBER OF WORK ORDERS IS (B)(4) PIECES. 2) ISOLATED PLUG INCOMING INSPECTION, NO ABNORMAL APPEARANCE AND SIZE, IN LINE WITH THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) (B)(4) OF LEAKAGE TEST IN PROCESS TESTING AND (B)(4) OF LEAKAGE TEST IN SHIPMENT TESTING, THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS. 4) IN THE PRODUCTION PROCESS, THERE IS NO CONFORMITY, DEVIATION OR REWORK BEHAVIOR. 5) ISOLATION PLUG ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. SAMPLE RETENTION SURVEY: 1) THE RETAINED SAMPLE OF THIS BATCH WAS TAKEN FOR RELATED TESTS: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST PASSED AND NO LEAKAGE WAS FOUND AT THE ISOLATION PLUG. CONCLUSION: DUE TO NO ABNORMALITY IN THE PROCESS AND RETAINED SAMPLE, THE CUSTOMER'S SAMPLE HAS BEEN USED, AND THE PRODUCT ISOLATION PLUG HAS SHIFTED WHEN THE SAMPLE IS RETURNED FROM THE CUSTOMER FOR SAMPLE ANALYSIS, AND THE PRODUCT IS USED IN THE CT INJECTION SCENARIO. THE PRODUCT IS NOT SUITABLE FOR HIGH-PRESSURE APPLICATION, AND IT IS RECOMMENDED THAT THE CUSTOMER USE A SPECIAL HIGH-PRESSURE INJECTION PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA II LEAKED WHILE INJECTING A MEDICATION IN THE CT ROOM, THE MEDICATION WAS LEFT OUT OF THE NEEDLE HOLDER, THE NEED TO CLAIM, NEED A LETTER OF RESPONSE TO COMPLAINT, NEED A LETTER OF RECEIPT OF COMPLAINT, THE DEFECTIVE PRODUCT CAN BE RETURNED, PHOTOS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613224 BD INTIMA II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171135 00382903830503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown