BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22609739 · Received July 25, 2025

    Report

    Report Number
    3006948883-2025-00336
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 20, 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#4233013): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN OCTOBER 2024 AND PACKAGED AT R240 PACKAGE LINE IN OCTOBER 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. 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 DAMAGE STATUS OF THE CATHETER CANNOT BE IDENTIFIED. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PRODUCTION PROCESS AND RETAINED SAMPLE AND AS NO DEFECTIVE SAMPLE IS RECEIVED FOR RELEVANT TESTING, THE DAMAGE STATUS OF THE CATHETER CANNOT BE IDENTIFIED, SO THE ROOT CAUSE OF THE DEFECT OF THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER DEFECTIVE/DAMAGED DURING THE INFUSION, THE INDWELLING NEEDLE WAS INSPECTED AND THE SOFT NEEDLE WAS DAMAGED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009788 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown