BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 14660207 · Received June 10, 2022

    Report

    Report Number
    3014704491-2022-00216
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 16, 2022
    Report Date
    May 24, 2022
    Manufacturer
    BD (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

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1203087. 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, A VIDEO WAS SUBMITTED OF THE ISSUE WAS SUBMITTED TO AID IN OUR INVESTIGATION. OUR ENGINEERS NOTED THAT THE VIDEO DISPLAYED AN INTIMA-II UNIT LEAKING FROM THE SEPTUM. THE ISSUE HAS BEEN CONFIRMED. BASED ON THEIR EVALUATION AND FEEDBACK FORM REGARDING THE NATURE OF USE, 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 THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER LEAKED FROM THE SEPTUM DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE HEAD NURSE IN THE RADIOLOGY DEPARTMENT REPORTED THERE WAS LEAKAGE FROM THE SEPTUM DURING INJECTION" "THE PATIENT UNDERWENT MAGNETIC RESONANCE EXAMINATION AND WAS INJECTED AT A RATE OF 2.5 ML /S".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290630 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1203087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown