BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21208711 · Received January 22, 2025

    Report

    Report Number
    3002601200-2025-00005
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 7, 2024
    Report Date
    February 18, 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, (B)(4) PCS WERE PERFORMED SEPTUM LEAKAGE TEST IN-PROCESS TEST AND (B)(4) PCS 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. NO DEFECTIVE SAMPLES HAVE BEEN RECEIVED FOR THE COMPLAINT, RETURNED ONE PHOTO, THE PHOTO SHOWS THAT NEEDLE IS NOT REMOVED OFF AND BLOOD CAN BE SEEN AT THE BOTTOM OF THE SEPTUM. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR SEPTUM LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 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 LEAKAGE AT SEPTUM. ON (B)(6) 2024 AT 13:00 AFTER COMPLETING VENIPUNCTURE ON THE CHILD, BLOOD WAS FOUND OOZING FROM THE WHITE ISOLATION PLUG OF THE CLOSED INDWELLING NEEDLE, WHICH WAS IMMEDIATELY REMOVED FROM THE CHILD AND REPLACED WITH A NEEDLE FOR A SECOND PUNCTURE, CAUSING SECONDARY VASCULAR DAMAGE TO THE CHILD AND INCREASING THE CHILD'S PAIN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714031 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