BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21668199 · Received March 21, 2025

    Report

    Report Number
    3002601200-2025-00131
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 27, 2025
    Report Date
    April 15, 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

    PRODUCTION RECORD CHECK (LOT#4081482): THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN APRIL 2024, AND PACKAGED IN CFS PACKAGING LINE IN APRIL 2024, WITH (B)(4) PIECES OF WORK ORDER. 400 LEAKAGE TESTS IN PROCESS TESTING AND 32 LEAKAGE TESTS IN SHIPMENT TESTING, THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS. IN THE PRODUCTION PROCESS, THERE IS NO NON-CONFORMITY, DEVIATION OR REWORK BEHAVIOR. ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. THE RETAINED SAMPLE WAS CONFIRMED, AND THE RETAINED SAMPLE OF THIS BATCH WAS TAKEN FOR RELATED TESTS: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST PASSED AND NO LEAKAGE WAS FOUND. THE CUSTOMER DID NOT RETURN SAMPLES AND PHOTOS AND CONFIRMED FROM THE CUSTOMER'S REPLY THAT THE CUSTOMER USED A HIGH-PRESSURE SYRINGE, WHICH IS NOT SUITABLE FOR HIGH-PRESSURE INJECTION. CONCLUSION: NO ABNORMALITY WAS FOUND IN THE PRODUCT PROCESS, AND THE INSPECTION RESULTS ALL MET THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE OCCURRENCE WAS THAT THE CUSTOMER USED HIGH-PRESSURE INJECTION IN THE PRODUCT, RESULTING IN ABNORMAL LEAKAGE. IT IS RECOMMENDED THAT THE CUSTOMER USE PRODUCTS SUITABLE FOR HIGH-PRESSURE, AND THE FACTORY WILL CONTINUE TO PAY ATTENTION TO SUCH DEFECTS.

    Additional Manufacturer Narrative · 0

    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 20GAX1.16IN PRN/EC SLM LEAKED AT SEPTUM ON (B)(6) 2025, AT 02:22, AFTER THE NURSE HAD INSERTED AN INDWELLING NEEDLE FOR THE PATIENT, AN ENHANCED CT SCAN WAS PERFORMED. AFTER THE SCAN WAS COMPLETE, IT WAS FOUND THAT CONTRAST MEDIUM WAS LEAKING FROM THE WHITE SKIN PLUG AT THE END OF THE INDWELLING NEEDLE, AS WELL AS BLOOD. THE INCIDENT WAS IMMEDIATELY REPORTED TO THE HEAD NURSE, WHO STOPPED USING THE NEEDLE, REMOVED IT, REPLACED IT IN A NEW POSITION, REINSERTED IT, AND REPORTED THE ADVERSE EVENT RELATED TO CONSUMABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906498 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown