BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21446905 · Received February 24, 2025

    Report

    Report Number
    3002601200-2025-00071
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 1, 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

    1. DHR/BHR REVIEW LOT#4081481: 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4); 2-SEPTUM BATCHES WHICH ARE USED IN THIS PRODUCT BATCH ARE 4082691, 4082690 AND 3362151. THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS; 3-THE LEAKAGE TEST RESULTS OF 800PCS IN PROCESS TESTING AND (B)(4) 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 2.CUSTOMER RETURNED TWO PHYSICAL SAMPLES AND TWO PHOTOS 1) THE PHOTOS SHOW THAT THE PRODUCT IS 20G PRODUCT AND THE BATCH NUMBER IS 4081841. ONE PHOTO SHOWS THAT THE PRODUCT HAS BEEN USED AND THERE IS BLOOD ON THE TAIL OF THE SEPTUM. THE OTHER PHOTO SHOWS THAT THE UNIT PACKAGE OF PRODUCT IS NOT OPENED. 2)THE RETURN SAMPLE SHOWS: ONE SAMPLE HAS BEEN USED, AND THERE IS BLOOD AT THE TAIL OF THE SEPTUM, OBSERVE THE TAIL OF SEPTUM OF THE PRODUCT, AND THE SEPTUM HOLE IS OBVIOUSLY LARGER THAN THE NORMAL PRODUCT; THE UNIT PACKAGE OF ANOTHER PRODUCT HAS BEEN OPENED, AND THE PRODUCT IS TAKEN FOR SEPTUM LEAKAGE TEST, THE TEST RESULT IS OK. 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. 2-THE PLANT HAS LAUNCHED CAPA TO FURTHER INVESTIGATE THE ROOT CAUSE. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PRODUCTION PROCESS, ALL THE TEST RESULTS WERE WITHIN THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS. THE RETURNED PHOTOS AND SAMPLES SHOWED THE LEAKAGE AT THE SEPTUM, FOR WHICH THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    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 (B)(6) HOSPITAL EMERGENCY DEPARTMENT ON FEBRUARY 5, TWO CASES OF PATIENTS PUNCTURE 383012 HIKING HORSE RETENTION NEEDLE INFUSION, PUNCTURE FIXED READY TO INFUSE WHEN FOUND AT THE ISOLATION PLUG A LARGE AMOUNT OF BLEEDING, THE NURSE THEN DEALT WITH THE REPLACEMENT. GOOGLE TRANSLATION: ON FEBRUARY 5, TWO PATIENTS IN THE EMERGENCY DEPARTMENT OF THE HOSPITAL WERE PUNCTURED WITH 383012 YIMA INDWELLING NEEDLES FOR INFUSION. AFTER THE PUNCTURE AND FIXATION WERE COMPLETED AND THE INFUSION WAS BEING PREPARED, A LARGE AMOUNT OF BLEEDING WAS FOUND AT THE ISOLATION PLUG, AND THE NURSE SUBSEQUENTLY REPLACED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403980 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081481 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown