BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER

    MDR report key: 9474974 · Received December 16, 2019

    Report

    Report Number
    3006948883-2019-01094
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 28, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050849. 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. ADDITIONALLY, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE DEVICE SUBMITTED. BASED ON THEIR EVALUATION AND 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 HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER HAS BEEN FOUND WITH DEFECTIVE TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: RADIOLOGY DEPARTMENT IN THE USE OF INTIMA NEEDLE FOR HIGH PRESSURE INJECTION, WHILE PUSHING CONTRAST AGENT INJECTION, THE LOCATION OF THE EXTENSION TUBE WAS BROKEN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER HAS BEEN FOUND WITH DEFECTIVE TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: RADIOLOGY DEPARTMENT IN THE USE OF INTIMA NEEDLE FOR HIGH PRESSURE INJECTION, WHILE PUSHING CONTRAST AGENT INJECTION, THE LOCATION OF THE EXTENSION TUBE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272138 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH Y ADAPTER INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050849

    Patients

    Seq Age Sex Outcome Treatment
    1 Other