BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21665553 · Received March 21, 2025

    Report

    Report Number
    3002601200-2025-00130
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 28, 2025
    Report Date
    April 10, 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

    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 DID NOT RETURN SAMPLES AND PHOTOS. 2. PRODUCTION RECORD CHECK (LOT#4052079): 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN APRIL 2024 AND PACKAGED IN R240 PACKAGING LINE AND CFS PACKAGING LINE IN APRIL 2024, WITH A WORK ORDER QUANTITY OF (B)(4) PIECES. 2) ISOLATED PLUG INCOMING INSPECTION, NO ABNORMAL APPEARANCE AND SIZE, IN LINE WITH THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) 800 LEAKAGE TESTS IN PROCESS TESTING AND 32 LEAKAGE TESTS IN SHIPMENT TESTING, THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS. 4) IN THE PRODUCTION PROCESS, THERE IS NO NON-CONFORMITY, DEVIATION OR REWORK BEHAVIOR. 5) ISOLATION PLUG 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, NO LEAKAGE WAS FOUND AT THE ISOLATION PLUG. 2) THE FACTORY HAS INITIATED CAPA FOR FURTHER ROOT CAUSE INVESTIGATION. CONCLUSION: NO ABNORMALITY WAS FOUND IN THE PRODUCT MANUFACTURING PROCESS, AND ALL TEST RESULTS WERE IN LINE WITH THE REQUIREMENTS OF PRODUCT SPECIFICATIONS. THE FACTORY HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED WHEN USING THE NEEDLE CORE, THE ISOLATION PLUG LEAKS BLOOD. THE SAMPLE CANNOT BE RETURNED, AND PHOTOS ARE PROVIDED; GREEN CLAIMS ARE REQUIRED, AND A COMPLAINT REPLY LETTER AND A RECEIPT LETTER ARE REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796576 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown