BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13970380 · Received March 31, 2022

    Report

    Report Number
    3014704491-2022-00123
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    February 25, 2022
    Report Date
    April 1, 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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230636. 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. BASED ON THE DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD INTIMA-II IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED 5 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE USE, IT WAS FOUND THAT THE INFUSION OF LIQUID MEDICINE WOULD LEAK AT THE CONNECTION BETWEEN THE PRN AND THE BLUE PLASTIC, SO THE CATHETER TUBE HAD TO BE RE-PLACED..."

    Description of Event or Problem · 0

    IT WAS REPORTED 5 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE USE, IT WAS FOUND THAT THE INFUSION OF LIQUID MEDICINE WOULD LEAK AT THE CONNECTION BETWEEN THE PRN AND THE BLUE PLASTIC, SO THE CATHETER TUBE HAD TO BE RE-PLACED..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2900876 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1230636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown