BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21574517 · Received March 11, 2025

    Report

    Report Number
    3002601200-2025-00119
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 16, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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 DID NOT RETURN THE SAMPLE BUT ONLY RETURNED A PHOTO. IN THE PHOTO, THE ANALYSIS NEEDLE HAS BEEN PULLED OUT, AND THERE IS BLOOD AT THE POSITION OF THE ISOLATION PLUG. 2. PRODUCTION RECORD CHECK (LOT#4233035): 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN SEPTEMBER 2024 AND PACKAGED IN CFS AND R240 PACKAGING LINE IN SEPTEMBER 2024. THE NUMBER OF WORK ORDERS IS (B)(4) PIECES. 2) SEPTUM INCOMING INSPECTION, NO ABNORMAL APPEARANCE AND SIZE, IN LINE WITH THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) 400 LEAKAGE TESTS IN PROCESS TESTING AND 32 LEAKAGE TESTS IN SHIPMENT TESTING, THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS. 4) THERE ARE NO NON-CONFORMITIES, DEVIATIONS OR REWORK DURING THE PRODUCTION PROCESS. 5) SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. CAUSE INVESTIGATION: 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: NO ABNORMALITY WAS FOUND IN THE PRODUCT MANUFACTURING PROCESS, AND ALL TEST RESULTS WERE IN LINE WITH THE REQUIREMENTS OF THE PRODUCT SPECIFICATION. THE FACTORY CONTINUES TO BE FOCUS ON THE DEFECT.

    Additional Manufacturer Narrative · 0

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16 IN PRN/EC SLM LEAKED AT SEPTUM ENDOCRINOLOGY DEPARTMENT RECENTLY FOUND THAT THE APPAREL ISOLATION PLUG CAN'T BE CLOSED WHEN USING APPAREL HORSE PUNCTURE CONTINUOUS BLOOD SEEPAGE, AT THE SAME TIME, FEEDBACK RECENTLY APPAREL HORSE AFTER WITHDRAWING THE NEEDLE CORE ESPECIALLY TIGHT, AT PRESENT, THIS HOSPITAL HAS BEEN REPORTED TO THE DEPARTMENT OF NAIL AND BREAST MEDICINE, INFECTION, GYNECOLOGY, SURGERY FOR APPAREL HORSE WITHDRAWING THE NEEDLE ASTRINGENT COMPLAINTS, CLINICAL SALES HAVE BEEN REDUCED BY ONE-THIRD TO ONE-HALF, BUT ALSO ASK THE QUALITY CONTROL AS FAR AS POSSIBLE TO SUPERVISE THE FACTORY TO IMPROVE THE PROCESS, THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336554 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233035 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown