BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21411490 · Received February 19, 2025

    Report

    Report Number
    1710034-2025-00261
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    February 3, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. HOWEVER, THE REPORTED DEFECT OF NEEDLE RETRACTION SLOW IS CONFIRMED SINCE A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE MODE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTIFY THE ROOT CAUSE. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA #.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT ADMITTED TO INTERVENTIONAL PULMONOLOGY FOR OUTPATIENT THORACENTESIS. PERIPHERAL IV PLACED PER PROTOCOL. 22G PLACED IN PT'S LEFT WRIST. WHEN IV WAS IN PLACE AND NEEDLE REMOVED, I PUSHED THE WHITE BUTTON ON THE DEVICE TO RETRACT THE NEEDLE INTO THE CLEAR HANDLE AND IT DID NOT RETRACT. I PUSHED THE WHITE BUTTON A SECOND TIME AND THEN IT RETRACTED INTO THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42449 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4229661 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown