BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 20GAX1.16IN PRN SLM

    MDR report key: 12200538 · Received July 20, 2021

    Report

    Report Number
    3006948883-2021-00817
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 6, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231176. 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. ALTHOUGH A SAMPLE COULD NOT BE PROVIDED, BASED ON THE DESCRIPTION OF THE EVENT, OUR TEAM OF QUALITY 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 WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTIMA-II 20GAX1.16IN PRN SLM LEAKED PAST THE SEPTUM, WHICH "POPPED OUT" DURING THE CT EXAM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE SEPTUM WAS POPPED OUT DURING CT EXAMINATION". "HIGH PRESSURE INJECTION WITH A PRESSURE VALUE NOT EXCEEDING 300PSI".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093914 INTIMA-II 20GAX1.16IN PRN SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0231176

    Patients

    Seq Age Sex Outcome Treatment
    1