BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21191458 · Received January 20, 2025

    Report

    Report Number
    1710034-2025-00034
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    January 2, 2025
    Report Date
    April 23, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814121
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF THE SAFETY NOT ENGAGING COULD NOT BE CONFIRMED FROM THE RETURNED 24GA INSYTE AUTOGUARD FROM LOT: 4152060. THE SAMPLE WAS RECEIVED WITH THE SAFETY MECHANISM ENGAGED AND THE NEEDLE FULLY RETRACTED WITHIN THE SHIELD. A FUNCTIONAL TEST AND VISUAL EXAMINATION REVEALED NO DAMAGE OR DEFECTS ASSOCIATED WITH THE MANUFACTURING PROCESS. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO ISSUES DURING THE PRODUCTION OF THIS BATCH. ALTHOUGH THE RETURNED SAMPLE AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    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: I ALSO HAVE 1 OF EA OF THE BELOW IN OTHER SIZES WITH SIMILAR ISSUES OF THE SAFETY NOT ENGAGING. I AM INCLUDING THOSE IN THE RETURN AS WELL. ADDITIONAL INFO: THE DATES REPORTED TO ME FOR ALL INCIDENCES WAS (B)(6)2025. NO ADVERSE OR SERIOUS EVENTS. I DON¿T HAVE THE TOTAL NUMBER OF OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525695 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152060 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown