BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22150875 · Received June 5, 2025

    Report

    Report Number
    3006948883-2025-00185
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    June 19, 2024
    Report Date
    June 11, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW (LOT#3171583): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JUL 2023 AND PACKAGED AT R240 PACKAGE LINE IN JUL 2023. 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. 3. PERFORMED 45PSI LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLES; NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR FURTHER TESTING, AND THE SPECIFIC LEAKAGE SITE AND ABNORMAL STATE OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED AT CATHETER JUNCTION DUE TO THERAPEUTIC NEEDS, THE NURSE DISCOVERED A LEAK AT THE STEM OF THE INDWELLING NEEDLE WHILE GIVING INFUSION THERAPY ON (B)(6) 2024. THE INDWELLING NEEDLE WAS IMMEDIATELY REPLACED AND THE VENIPUNCTURE CANNULATION WAS CONTINUED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937620 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3171583 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown