BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25243470 · Received May 21, 2026

    Report

    Report Number
    1710034-2026-00546
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. INJURIES OR ADVERSE EVENT: NO. PIV, NEEDLE WOULD NOT RETRACT CAUSING SHARP TO BE EXPOSED AND ADDITION PIV PLACED. THE DATE OF THE EVENT IS (B)(6) 2026. I'VE ATTACHED TO PHOTO THAT WAS PROVIDED BY THE UNIT BELOW, BUT IT IS BLURRY AND HARD TO SEE THE LOT# CLEARLY. ACCORDING TO THE REPORTING NURSE SHE COULD NOT DEPRESS THE ACTIVATION BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133959 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1