BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22576972 · Received July 23, 2025

    Report

    Report Number
    3006948883-2025-00325
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 12, 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. PRODUCTION RECORD CHECK (LOT#4081482): 1)THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN INTIMA II AUTOMATIC LINE 4 IN APRIL 2024, AND PACKAGED IN R240 PACKAGING LINE IN APRIL 2024, WITH (B)(4) PIECES OF WORK ORDER; 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. 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 (PVC EXTENSION TUBING, Y CONNECTION SITE), 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. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE SINCE THE PRODUCT IS NOT SUITABLE FOR HIGH PRESSURE INJECTION, THE ROOT CAUSE OF THE JOINT TO BURST MAY BE RELATED TO THE INCORRECT USE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED WITH POWER INJECTOR (B)(6) 2025 THE PATIENT'S CONDITION NEEDS TO GO TO THE CT ROOM ACCOMPANIED BY A PHYSICIAN TO DO CTA EXAMINATION, IN THE CT ROOM LINE HIGH-PRESSURE SYRINGE PUSHED THE CONTRAST AGENT, FOUND THAT THE CONNECTOR OF THE INDWELLING NEEDLE BLEW UP, CAREFUL OBSERVATION AND INSPECTION DID NOT SEE BLOOD SEEPAGE, SO IMMEDIATELY AFTER THE CTA EXAMINATION IMMEDIATELY RETURNED TO THE WARD, FOR THE REMOVAL OF THE NEEDLE, PRESSURE TO STOP THE BLEEDING, FOR THE TIME BEING, DID NOT CAUSE ANY HARM TO THE PATIENT

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785566 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown