BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 15562575 · Received October 7, 2022

    Report

    Report Number
    3014704491-2022-00472
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 1, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830077
    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

    IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110983. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. 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-II 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-II 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 BROKE FROM THE HUB AND LEAKED DURING THE CT SCAN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "(B)(6) 2022 THE PATIENT WAS CLINICALLY DIAGNOSED WITH CHEST TIGHTNESS AND ARRHYTHMIA. HE CAME TO THE RADIOLOGY DEPARTMENT OF THE HOSPITAL FOR CORONARY CTA, AND WAS INJECTED WITH IOHEXOL USING A CLOSED INTRAVENOUS INDWELLING NEEDLE. THE INDWELLING NEEDLE WAS INTACT WHEN INDWELLING. DURING THE CT SCAN, THE TUBE OF THE INDWELLING NEEDLE SUDDENLY BROKEN AND THE LIQUID LEAKED OUT. THE INDWELLING NEEDLE WAS REPLACED IMMEDIATELY. THE PATIENT COMPLAINED THAT HE HAD NO DISCOMFORT. HE WAS COMFORTED IMMEDIATELY AND A NEW INDWELLING NEEDLE WAS REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080127 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110983 00382903830077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown