BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 21450285 · Received February 24, 2025

    Report

    Report Number
    3002601200-2025-00074
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 14, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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 HAS NO SAMPLE PHOTO TO RETURN 2. PRODUCTION RECORD CHECK (LOT#4052015) : 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN APRIL 2024, AND PACKAGED IN R240 PACKAGING LINE IN APRIL 2024. THE NUMBER OF WORK ORDERS IS (B)(6) 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 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 RELEVANT TESTING: NO LEAKAGE WAS FOUND AT THE ISOLATION PLUG, AND THE TEST REPORT IS ATTACHED PR#11540357; 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 THE PRODUCT SPECIFICATION. NO SIMILAR COMPLAINTS WERE RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. IN RESPONSE TO THIS DEFECT, THE FACTORY HAS INITIATED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED AT SEPTUM XIANGMA ISOLATION PLUG LEAKAGE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402488 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown