BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21698678 · Received March 26, 2025

    Report

    Report Number
    3006948883-2025-00020
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    October 16, 2024
    Report Date
    April 10, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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 DOES NOT RETURN SAMPLES AND PHOTOS. 2. PRODUCTION RECORD CHECK (LOT#4081456): 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 2 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) (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 NON-CONFORMITY, DEVIATION OR REWORK BEHAVIOR. 5) ISOLATION PLUG ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. CAUSE INVESTIGATION: 1) (B)(4) OF THE BATCH OF RETAINED SAMPLES WERE 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 PRODUCTION PROCESS, AND THE TEST RESULTS WERE IN LINE WITH THE REQUIREMENTS OF THE PRODUCT SPECIFICATION. THE CUSTOMER DID NOT RETURN SAMPLES AND PHOTOS, IN RESPONSE TO THIS DEFECT, THE FACTORY HAS INITIATED CAPA TO TRACE AND INVESTIGATE THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED AT SEPTUM PATIENT WAS HYDRATED AFTER 10.16 CORONARY ANGIOGRAM AND WAS TO BE INFUSED WITH AN INDWELLING NEEDLE, BLOOD RETURNED TO THE FROM THE ISOLATION PLUG DURING THE PUNCTURE OF THE INDWELLING NEEDLE CAUSING THE PATIENT TO NEED TO HAVE THE NEEDLE RE-RETAINED, TO BE REPLACED WITH A NEW NEEDLE TO BE RE-RETAINED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694847 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081456 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown