BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20553042 · Received October 28, 2024

    Report

    Report Number
    1710034-2024-01219
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 4, 2024
    Report Date
    December 12, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE 22GX1.00IN INSYTE AUTOGUARD DEVICE FROM LOT NUMBER 4030766. YOUR REPORTED ISSUE OF THE SAFETY MECHANISM NOT ENGAGING COULD NOT BE CONFIRMED FROM THE USED NEEDLE THAT WAS RECEIVED FROM A 22G INSYTE AUTOGUARD UNIT. THE NEEDLE WAS RECEIVED FULLY RETRACTED WITHIN THE SHIELD. THERE WERE NO DAMAGES IDENTIFIED ON THE SAFETY BUTTON, HUB, SPRING AND EVEN THE BARREL. THE NEEDLE WAS REENGAGED BY PUSHING IT OUT OF THE BARREL THEN RETRACTED BY PUSHING THE SAFETY BUTTON. THE NEEDLE RETRACTED WITHOUT RESISTANCE. THERE WERE NO DEFECTS ASSOCIATED WITH THE MANUFACTURING PROCESS IDENTIFIED ON THE RETURNED SAMPLE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEVERAL REPORTS OF SAFETY NOT ENGAGING ON PERIPHERAL IV CATHETERS. PREVIOUSLY PUT IN A SAFETY NET ON 24G AND NOW EXPERIENCING WITH 22G CATHETERS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339155 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030766 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown