BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II

    MDR report key: 22773173 · Received August 11, 2025

    Report

    Report Number
    3006948883-2025-00437
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 21, 2025
    Report Date
    September 4, 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

    1. DHR/BHR REVIEW(LOT#4243811): 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. BATCH SIZE IS 198000 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 PHOTOGRAPH HAVE BEEN RECEIVED, AND BASED ON THE LIMITED INFORMATION, IT IS DIFFICULT TO DETERMINE THE SPECIFIC LEAKAGE SITE OF THE INDWELLING NEEDLE. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, THE TEST RESULT SHOWED THAT NO LEAKAGE WAS FOUND ON THE SAMPLE. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. BECAUSE 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.

    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 BD INTIMA-II LEAKED. THE CHILD WAS TREATED AT OUR HOSPITAL FOR A DIAGNOSIS OF PNEUMONIA. AT 10:20 A.M. ON (B)(6) AFTER CONNECTING THE SALINE SOLUTION TO VENTILATE THE PATIENT PRIOR TO PERFORMING AN INDWELLING NEEDLE PUNCTURE, FLUID LEAKAGE WAS FOUND AT THE INTERFACE OF THE CLOSED IV NEEDLE. IT WAS IMMEDIATELY STOPPED, REPLACED WITH A NEW INDWELLING NEEDLE AND REPORTED WITHOUT HARM TO THE CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902837 BD INTIMA-II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4243811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown