BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 15447514 · Received September 19, 2022

    Report

    Report Number
    3014704491-2022-00420
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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

    INITIAL REPORTER PHONE#: UNKNOWN INITIAL REPORTER E-MAIL: UNKNOWN INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110984. 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¿ IV CATHETER PRN ADAPTER TUBING RUPTURED DURING THE CT EXAM AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT 11:40, ON(B)(6)2022. , THE PATIENT WAS SENT TO THE CT ROOM FOR ENHANCED CT EXAMINATION. AT 11:50, THE STAFF IN THE CT ROOM CALLED ABOUT A 5MM RUPTURE IN THE DISTAL END OF THE INDWELLING NEEDLE EXTENSION HOSE, AND THE PATIENT'S INDWELLING NEEDLE EXTENSION HOSE WAS SPRAYED WITH WATER. THE INDWELLING NEEDLE WAS IMMEDIATELY CLOSED AND THE PATIENT WAS COMFORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603396 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110984 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown