BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22437787 · Received July 8, 2025

    Report

    Report Number
    3006948883-2025-00271
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    September 24, 2024
    Report Date
    July 23, 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 SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST AND PRN REMOVAL TORQUE TEST, THE LEAKAGE TEST IS QUALIFIED, THERE IS NO LEAKAGE AT THE PRN, AND THE PRN REMOVAL TORQUE IS WITHIN THE PRODUCT SPECIFICATIONS. 4. POSSIBLE CAUSE: DURING THE ASSEMBLY OF THE PRN, MALOCCLUSION OCCURRED, THAT IS, THE PRN LUER AND THE PP CONNECTOR LUER ARE NOT OCCLUDED CORRECTLY, RESULTING IN EACH OTHER'S LUER DAMAGE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THE ROOT CAUSE OF THE PRN CANNOT BE TIGHTENED CANNOT BE DETERMINED BECAUSE THE DEFECTIVE SAMPLE IS NOT RECEIVED FOR ANALYSIS AND CONFIRMATION AND THE USAGE OF THE SAMPLE IS UNKNOWN.THE PLANT WILL CONTINUE TO FOCUS ON SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CAP WAS LOOSE AND LEAKED THE PATIENT WAS ADMITTED TO OUR HOSPITAL ON (B)(6) 2024 DUE TO HEART FAILURE AND WAS GIVEN INTRAVENOUS INFUSION WITH A CANNULA. AT 9:00 ON (B)(6) 2024, WHEN THE INFUSION WAS RESUMED, FLUID LEAKED FROM THE PRN CONNECTION OF THE CANNULA, AND THE PRN WAS LOOSE AND COULD NOT BE TIGHTENED. IT WAS REPLACED WITH A NEEDLE-FREE STREET CONNECTOR AND THE INFUSION CONTINUED WITHOUT CAUSING ANY 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
    373972 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