BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18297219 · Received December 8, 2023

    Report

    Report Number
    3014704491-2023-00808
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 12, 2023
    Report Date
    March 5, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    PMA / PMN Number
    NA
    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#3052814): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2023, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 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. 2. NO ACTUAL SAMPLES AND PHOTOS RETURNED. 3. TAKE THE RETAINED SAMPLE OF THE COMPLAINT BATCH FOR RELEVANT FUNCTIONAL TESTING: 1) 45PSI LEAKAGE TEST IS PERFORMED, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE PRN. 2) PRN REMOVE TORQUE TEST IS CARRIED OUT, AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORTS. 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. 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 PRN FALLING OFF 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 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; WHEN THE HIGH-PRESSURE SYRINGE IS USED TO QUICKLY PUSH THE CONTRAST MEDIUM, THE HEPARIN CAP FALLS OFF, CAUSING EXTRAVASATION OF BLOOD AND CONTRAST MEDIUM, CAUSING THE EXAMINATION TO FAIL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780247 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3052814 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown