BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15277383 · Received August 23, 2022

    Report

    Report Number
    3014704491-2022-00372
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 9, 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 BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230637. 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, OUR ENGINEERS 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 IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. BD ENCOURAGES THE REVIEW OF THE INSTRUCTIONS FOR USE INCLUDED WITH ALL INTIMA UNITS; BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE MEDICAL STAFF USED A CLOSED VEIN INDWELLING NEEDLE TO INJECT CONTRAST MEDIUM INTO THE PATIENT, THE INDWELLING NEEDLE RUPTURED, RESULTING IN THE OUTFLOW OF CONTRAST MEDIUM, WASTING THE INDWELLING NEEDLE, ESPECIALLY THE CONTRAST MEDIUM, AND RESULTING IN SLIGHT DISCOMFORT OF THE PATIENT. THE CLOSED INDWELLING NEEDLE WAS REPLACED AND RE-INJECTED TO COMPLETE THE ANGIOGRAPHY OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806685 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1230637

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown