BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC BLU 22GA X 1.0IN

    MDR report key: 18646420 · Received February 5, 2024

    Report

    Report Number
    1710034-2024-00078
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 24, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WOULD NOT RETRACT COULD NOT BE CONFIRMED FROM THE 27 REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED FROM LOT #3142657. A VISUAL AND FUNCTIONAL TEST OF THE RETURNED SAMPLES REVEALED NOTHING REMARKABLE. EACH NEEDLE FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED. ALTHOUGH THE REPRESENTATIVE SAMPLES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE AUTOG BC BLU 22GA X 1.0IN NEEDLE WILL NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WILL NOT RETRACT."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955610 BD INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3142657 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown