BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 13197237 · Received January 7, 2022

    Report

    Report Number
    3014704491-2021-00422
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    October 12, 2021
    Report Date
    January 23, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLE OR PHOTO WAS RECEIVED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111460 . OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. THE BD INTIMA-II IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. 2 RETAINED SAMPLES OF THIS LOT WERE TAKEN FOR HIGH-PRESSURE BLASTING TEST, ALL PASSED THE TEST, THERE WAS NO LEAKAGE BETWEEN THE CONNECTION SITE AND HIGH PRESSURE CONNECTOR H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED BD INTIMA-II 20GAX1.16IN PRN SLM NPVC HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DURING CT ENHANCEMENT, FLUID LEAKAGE WAS FOUND AT THE TRANSFER OF INDWELLING NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD INTIMA-II 20GAX1.16IN PRN SLM NPVC HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "DURING CT ENHANCEMENT, FLUID LEAKAGE WAS FOUND AT THE TRANSFER OF INDWELLING NEEDLE...".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516992 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1111460

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown