BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 22677781 · Received July 31, 2025

    Report

    Report Number
    3006948883-2025-00348
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 5, 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. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW(LOT#4233035): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN (B)(6) 2024, AND PACKAGED AT CFS PACKAGE LINE IN (B)(6) 2024. WORK ORDER QUANTITY WAS (B)(4). 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. FUNCTION TEST (45PSI LEAKAGE TEST) IS PERFORMED ON RETAINED SAMPLE OF THE COMPLAINT BATCH, THE RESULT IS QUALIFIED, NO LEAKAGE IS FOUND. 4. SKU#383012 IS AN INTIMA II PRODUCT, WHICH HAS NOT BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. THE INTENDED USE FOR THE BD INTIMA II PRODUCT IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. 5. 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. SINCE THE PRODUCT IS NOT SUITABLE FOR HIGH PRESSURE INJECTION, THE ROOT CAUSE OF THE SUDDEN BURSTING OF THE INDWELLING NEEDLE AND TUBING CANNOT BE CONFIRMED TO BE RELATED TO THE PRODUCTION.

    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 Y 20GAX1.16IN PRN/EC SLM LEAKED WITH POWER INJECTOR UNPACKING AND USE OF INDWELLING NEEDLE TUBING FOUND TO BURST OPEN. NEW INFORMATION RECEIVED ON 07/07/2025: AFTER COMMUNICATING WITH THE HOSPITAL'S CLINICAL TEACHERS, IT WAS CONFIRMED THAT THE PROBLEM WAS CAUSED BY IMPROPER USE OF THE INTIMA II, WHICH IS NOT RESISTANT TO HIGH PRESSURE, FOR HIGH-PRESSURE ANGIOGRAPHY, WHICH CAUSED A TUBE BURST. THE HOSPITAL HAS EXPLAINED THE PROBLEM TO THE HOSPITAL'S EQUIPMENT DEPARTMENT TEACHERS AND CLINICIANS, AND THE HOSPITAL AGREES TO ACCEPT THE EXPLANATION. IN THE FUTURE, THE CLINIC WILL SWITCH TO USING THE HIGH-PRESSURE RESISTANT XIANGMA PRODUCTS. NO PICTURES OF THE PROBLEMATIC PRODUCTS ARE CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165405 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown