BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21855305 · Received April 17, 2025

    Report

    Report Number
    1710034-2025-00608
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 5, 2025
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, IL WAS USED AS THE STATE PLACE HOLDER. CORRECTION: CANCEL MDR. THE LOT NUMBER 4123600 PROVIDED CANNOT BE VERIFIED IN ASSOCIATION WITH THE REPORTED MATERIAL NUMBER. IT WAS DETERMINED THAT THIS LOT NUMBER MIGHT BE ASSOCIATED WITH MATERIAL # 381412 AND ANOTHER COMPLAINT RECORD WAS OPENED AND AN MDR WAS FILED. ASSOCIATED MFR # 1710034-2025-00591.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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, XX WAS USED AS A PLACE HOLDER. THE LOT NUMBER 4123600 PROVIDED CANNOT BE VERIFIED IN ASSOCIATION WITH THE REPORTED MATERIAL NUMBER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER IS COMING OFF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANULA COMING OFF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682145 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown