BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 22436921 · Received July 8, 2025

    Report

    Report Number
    1710034-2025-01148
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 26, 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
    IL, US
    Reporter Occupation
    003

    Narratives

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, (B)(6) WAS USED AS THE STATE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT THAT THE NEEDLE WOULD NOT DISCONNECT FROM THE IV CATHETER COULD NOT BE CONFIRMED FROM THE PHOTOGRAPH THAT WAS PROVIDED FOR INVESTIGATION. THE PHOTO SHOWED THE UNIT PACKAGING FOR A 24G INSYTE AUTOGUARD DEVICE. THE NEEDLE AND IV CATHETER WERE NOT VISIBLE IN THE PHOTO. ALTHOUGH THE PHOTOGRAPH 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

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PLACING A PERIPHERAL IV ON THIS PATIENT, FOR A SEDATED MRI, THE REPORTING CAREGIVER WENT TO PULL THE IV NEEDLE OUT OF THE CATHETER/ADVANCE THE CATHETER, BUT THE NEEDLE WOULDN'T DISCONNECT. SHE REMOVED THE IV FROM THE PATIENT, AND PUSHED THE BUTTON ON THE IV, WHICH IS MEANT TO RETRACT THE NEEDLE INSIDE THE HANDLE TO PROTECT FROM NEEDLESTICK INJURY. WHEN SHE PUSHED THE BUTTON, THE NEEDLE DID NOT RETRACT, WHICH CONTINUED WITH 2 MORE ATTEMPTS TO HIT THE BUTTON. SHE THEN CARRIED THE IV DIRECTLY OVER TO THE SHARP¿S CONTAINER, AND BEFORE SHE DROPPED IT IN, THE NEEDLE RETRACTED ON ITS OWN, WITHOUT ANY CONTACT WITH THIS BUTTON, AND CAME UNATTACHED FROM THE CATHETER PORTION OF THE IV. THE REPORTING CAREGIVER THEN DISPOSED OF THE NEEDLE IN THE SHARP¿S CONTAINER. WAS THERE INJURY? NO. REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158050 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4241248 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown