BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22102039 · Received May 28, 2025

    Report

    Report Number
    3006948883-2025-00157
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    PMA / PMN Number
    NA
    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#4233017): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEP 2024, AND PACKAGED AT R240 PACKAGE LINE IN SEP 2024. WORK ORDER QUANTITY WAS 198,000 EA. 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 SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT; THE STATE AND COMPOSITION OF THE FOREIGN MATTER CANNOT BE CONFIRMED. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTER WAS SEEN. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED THE CONDITION AND COMPOSITION OF THE FOREIGN MATTER CANNOT BE CONFIRMED, 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 THE BD INTIMA-II 24GAX0.75IN PRN SLM NPVC HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025 DURING THE PROCESS OF PLACING AN INTRAVENOUS CANNULA IN A PEDIATRIC PATIENT, PLASTIC BURRS WERE FOUND. THE CANNULA WAS IMMEDIATELY REPLACED FOR USE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588929 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 4233017 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown