BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 12943320 · Received December 6, 2021

    Report

    Report Number
    3014704491-2021-00329
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    September 25, 2021
    Report Date
    December 25, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. 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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111460. 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 PEGASUS 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 PEGASUS UNITS; BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA-II 20GAX1.16IN PRN SLM NPVC THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE WHITE CAP AT THE CONNECTION BETWEEN THE HIGH-PRESSURE SYRINGE AND THE CLOSED VEIN INDWELLING NEEDLE FELL OFF AFTER THE NURSE ROUTINELY PUNCTURED THE CLOSED VEIN INDWELLING NEEDLE AND INJECTED IODINE CONTRAST AGENT AT HIGH PRESSURE. THIS RESULTED IN DRUG EXTRAVASCULAR, AND THE EXAMINATION FAILED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA-II 20GAX1.16IN PRN SLM NPVC THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE WHITE CAP AT THE CONNECTION BETWEEN THE HIGH-PRESSURE SYRINGE AND THE CLOSED VEIN INDWELLING NEEDLE FELL OFF AFTER THE NURSE ROUTINELY PUNCTURED THE CLOSED VEIN INDWELLING NEEDLE AND INJECTED IODINE CONTRAST AGENT AT HIGH PRESSURE. THIS RESULTED IN DRUG EXTRAVASCULAR, AND THE EXAMINATION FAILED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840298 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1111460

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown