BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 22163806 · Received June 7, 2025

    Report

    Report Number
    3006948883-2025-00191
    Event Type
    Malfunction
    Date Received
    June 7, 2025
    Date of Event
    May 7, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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#4145146): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN JUN, 2024, AND PACKAGED AT R240 PACKAGE LINE IN JUN, 2024. BATCH SIZE IS (B)(4) EA. 2)IN THIS BATCH, 800 PCS WERE PERFORMED SEPTUM LEAKAGE TEST IN-PROCESS TEST AND 32PCS IN OUTGOING TEST, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4)SEPTUM BATCH USED IN THIS BATCH IS 4141837, REVIEW THE RAW MATERIAL INSPECTION RECORDS, DIMENSION AND APPEARANCE HAVE NO ABNORMALITIES, WHICH BOTH MEET SPECIFICATION 5)CHECK THE MAINTENANCE RECORD OF THE SEPTUM RELATED ASSEMBLY EQUIPMENT, NO ABNORMAL MAINTENANCE. 2. THE CUSTOMER RETURNED 1 PHOTO, NO DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE SAMPLE HAS BEEN USED, THE NEEDLE HAS BEEN REMOVED, AND NO COMPLAINTS OR DEFECTS HAVE BEEN OBSERVED. 3. PERFORMED 45PSI LEAKAGE TEST AND SEPTUM LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. 4. POSSIBLE CAUSES: 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. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PROCESS AND RETAINED SAMPLES, BECAUSE NO SAMPLES WAS RETURNED, DEEP ANALYSIS IS UNAVAILABLE , SO THE ROOT CAUSE OF THE LEAKAGE COULD NOT BE CONFIRMED, PLANT WILL CONTINUE TRACKING THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025, WITH A DIAGNOSIS OF ¿ACUTE MYELOID LEUKEMIA¿ DUE TO DIZZINESS AND FATIGUE FOR MORE THAN EIGHT MONTHS. ON (B)(6) 2025, DURING INTRAVENOUS INFUSION, A CLOSED VENOUS CANNULA WAS USED. AFTER SUCCESSFUL PUNCTURE AND CONNECTION OF THE FLUID, FLUID AND BLOOD WERE FOUND TO BE LEAKING FROM THE REAR END OF THE CANNULA. THE CANNULA WAS IMMEDIATELY RETRIEVED, AND THE PATIENT WAS REASSURED. AND REPLACED IT WITH A NEW CLOSED VENOUS CANNULA. THIS CAUSED SECONDARY INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463107 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4145146 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown