BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22459411 · Received July 9, 2025

    Report

    Report Number
    3006948883-2025-00275
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    November 29, 2024
    Report Date
    July 24, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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. DHR/BHR REVIEW(LOT#4081489): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APR 2024, AND PACKAGED AT R240 PACKAGE LINE IN APR 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2)REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR 45PSI LEAKAGE TEST AND PRN REMOVAL TORQUE TEST.THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATION. 4. IN THE ASSEMBLY PROCESS OF PRN, THERE ARE TORQUE AND ASSEMBLY STROKE MONITORING TO ENSURE THAT THE LUER OF PRN CAN BE ASSEMBLED INTO THE PP CONNECTOR TO A CERTAIN DEPTH AND THE THREAD HAS A GOOD FASTENING EFFECT. IF THE PRN IS NOT IN PLACE, THE EQUIPMENT WILL ALARM AND REMOVE THE PRODUCT. HOWEVER, ALTHOUGH PRN IS FASTENED TO THE PRODUCT DURING ASSEMBLY, IT MAY COME LOOSE IF IT IS VIBRATED DURING TRANSPORTATION. THEREFORE, THE IFU OF THE PRODUCT INDICATES THAT THE PRN SHOULD BE TIGHTENED BEFORE USE TO PREVENT LEAKAGE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. AS THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, SO THE ROOT CAUSE OF THE PRN LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND MONITOR SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKAGE THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ACUTE MYOCARDIAL INFARCTION, AND WAS GIVEN INTRAVENOUS INFUSION THERAPY WITH AN INFUSION INDWELLING NEEDLE ON NOVEMBER 29, 2024, AT 9:00 P.M. ABOUT ONE HOUR AFTER THE INFUSION, A LEAKAGE OF THE PROTECTIVE CAP OF THE CONICAL CONNECTOR OF THE INDWELLING NEEDLE WAS FOUND; THE INDWELLING NEEDLE WAS INTACT, AND A DISPOSABLE NEEDLE-LESS CONNECTOR WAS USED TO REPLACE THE PROTECTIVE CAP, CAUSING NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148654 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown