BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM

    MDR report key: 12828455 · Received November 17, 2021

    Report

    Report Number
    3014704491-2021-00267
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    August 24, 2021
    Report Date
    October 27, 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

    DATE OF BIRTH WAS NOT PROVIDED (B)(6) WAS AN ESTIMATED DATE OF BIRTH. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020939. 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. ADDITIONALLY, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE PHOTOGRAPH SUBMITTED. BASED ON THEIR EVALUATION AND THE DESCRIPTION OF THE EVENT, THEY 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA-II 20GAX1.16IN PRN SLM THE NEEDLE WAS DAMAGE AND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PATIENT WAS GIVEN 20G INDWELLING NEEDLE. AFTER CATHETERIZATION OF THE PATIENT'S RIGHT ELBOW VEIN WAS PREPARED, THE GROUP INJECTION WAS PERFORMED AT A SPEED OF 3.5ML AT 9:34, AND THE INDWELLING NEEDLE BURST AT ABOUT 50-60MI, THE INJECTION WAS STOPPED IMMEDIATELY AND NEEDLE EXTRACTION WAS GIVEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730483 BD INTIMA-II 20GAX1.16IN PRN SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1020939

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female