BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21356095 · Received February 11, 2025

    Report

    Report Number
    3002601200-2025-00050
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 16, 2025
    Report Date
    March 21, 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

    SUMMARY 1. NO SAMPLES AND PHOTOS WILL BE RETURNED. 2. DHR/BHR REVIEW LOT#3052815 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2023, AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)(4) PCS; 2-THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS; 3-THE LEAKAGE TEST RESULTS OF 400PCS IN PROCESS TESTING AND 32PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS; 4-NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS; 5-THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. CAUSE INVESTIGATION: 1-RETAINED SAMPLES OF THIS BATCH WERE TAKEN FOR RELATED TEST: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST RESULTS SHOWED THAT NO LEAKAGE WAS FOUND AT THE SEPTUM. NO ABNORMALITY WAS FOUND IN THE PRODUCTION PROCESS, ALL THE TEST RESULTS WERE WITHIN THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS, AND NO SIMILAR COMPLAINTS ABOUT THIS BATCH OF PRODUCTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS.

    Additional Manufacturer Narrative · 0

    H.3. 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 PROVIDED.

    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 10:00, THE PATIENT HAD AN UPPER SENSATION AND CHEST TIGHTNESS, AND WAS ADMITTED TO THE RESUSCITATION ROOM TO FOLLOW THE DOCTOR'S ORDERS FOR BLOOD COLLECTION AND INDWELLING VENOUS ACCESS, AND THE NURSE CHECKED THAT THE INDWELLING NEEDLE WAS OKAY BEFORE USING IT TO PERFORM THE INDWELLING PUNCTURE, AND THE PUNCTURE WAS SUCCESSFUL IN SEEING THE RETURN OF BLOOD AND PULLING OUT THE PUNCTURE NEEDLE, AND AFTER THAT, SEEING THAT THERE WAS CONSTANT BLOOD COMING OUT OF THE END OF THE NEEDLE BOLUS, AND THE PATIENT'S PAIN WAS AGGRAVATED BY THE IMMEDIATE REMOVAL OF THE TUBING AND RE-PUNCTURING OF THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836476 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3052815 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown