BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II

    MDR report key: 22284666 · Received June 18, 2025

    Report

    Report Number
    3006948883-2025-00208
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 11, 2025
    Report Date
    June 26, 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#4171713): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JUL 2024 AND PACKAGED AT R240 PACKAGE LINE IN JUL 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. BASED ON THE LIMITED INFORMATION, IT IS DIFFICULT TO DETERMINE THE SPECIFIC LEAKAGE SITE OF THE INDWELLING NEEDLE. 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 RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. 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 THE TREND OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II LEAKED AT ADAPTER TUBING JUNCTION DURING INTRAVENOUS TREATMENT, A CANNULA WAS INSERTED. TWO MINUTES LATER, FLUID LEAKAGE WAS FOUND AT THE Y-SHAPED CONNECTION OF THE CANNULA. THE PATIENT WAS INFORMED OF THE SITUATION, AND THE CANNULA WAS REMOVED AND REINSERTED WITHOUT AFFECTING THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723903 BD INTIMA-II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171713 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown