BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 26GAX0.56IN SSPRN SLM NPVC

    MDR report key: 21850731 · Received April 16, 2025

    Report

    Report Number
    3006948883-2025-00077
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 9, 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

    1. DHR/BHR REVIEW(LOT#4012406): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT MANUAL LINE IN JAN 2024, AND PACKAGED AT R245 PACKAGE LINE IN FEB 2024. WORK ORDER QUANTITY WAS (B)(4) PCS 2)REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST, THE TESTS ARE PASSED, AND NO LEAKAGE IS FOUND AT THE SEPTUM AND OTHER PARTS OF THE SAMPLE. THE RETAINED SAMPLE OF THE COMPLAINED BATCH IS TAKEN FOR PRN TORQUE TEST, AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 4. ABOUT LEAKAGE OF SEPTUM: 1)AFTER THE NEEDLE IS PIERCED INTO THE VEIN, THERE IS BLOOD AT THE NOTCH OF THE NEEDLE. IN THE PROCESS OF NEEDLE REMOVAL, ALTHOUGH THE PERFORATION OF THE SEPTUM IS CLOSED, THE BLOOD DROPS IN THE NOTCH WILL BE BROUGHT OUT WITH THE NOTCH. IF THERE IS A LOT OF INERTIA IN THE NEEDLE REMOVAL PROCESS, BLOOD DROPS WILL BE THROWN OUT. 2)IF THE PATIENT'S ARM IS TIED TIGHT DURING THE PUNCTURE, IT WILL CAUSE GREAT PRESSURE IN THE VEIN, AND BLOOD WILL COME OUT WITH THE NEEDLE WHEN THE NEEDLE IS PULLED OUT, BUT THE SUBSEQUENT BLOOD LEAKAGE WILL NOT BE SUSTAINED. 5. ABOUT PRN LOOSE LEAKAGE: 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, IT IS RECOMMENDED TO TIGHTEN THE PRN BEFORE USE TO PREVENT LEAKAGE. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PRODUCTION PROCESS, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO AND MONITOR SUCH DEFECTS.

    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 AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 26GAX0.56IN SSPRN SLM NPVC LEAKAGE AT SEPTUM HOSPITAL REPORTED: FOUND DURING USE, ISOLATION PLUGS SEEPING BLOOD, QUANTITY 2; HEPARIN CAP LOOSENING LEADING TO BLOOD SEEPAGE, QUANTITY 6, TOTAL NUMBER OF AFFECTED 8, SAMPLES COULD NOT BE RETURNED, PHOTOGRAPHS CAN BE PROVIDED, GREEN CLAIMS ARE REQUIRED, NO LETTER OF RESPONSE TO COMPLAINTS, NO LETTER OF RECEIPT OF COMPLAINTS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114803 BD INTIMA-II Y 26GAX0.56IN SSPRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4012406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown