BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21378904 · Received February 13, 2025

    Report

    Report Number
    3002601200-2025-00059
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 16, 2025
    Report Date
    March 21, 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

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

    Additional Manufacturer Narrative · 0

    SUMMARY 1. NO SAMPLES AND PHOTOS WILL BE RETURNED. 2. PRODUCTION RECORD CHECK LOT#4081466 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 2 IN MAY 2024, AND PACKAGED IN CFS 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) 400 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 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. NO SIMILAR COMPLAINTS WERE RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED AT SEPTUM AFTER GIVING THE CHILD A VENIPUNCTURE ON (B)(6) 2025, WHEN THE STEEL NEEDLE WAS REMOVED, THE INDWELLING NEEDLE ISOLATION PLUG LEAKED BLOOD, POTENTIALLY POSING A RISK OF VENOUS INFECTION. THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED AND A REPLACEMENT INDWELLING NEEDLE WAS GIVEN TO REINTRODUCE THE IV WITHOUT FURTHER BLOOD LEAKAGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868341 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081466 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown