BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25303201 · Received May 27, 2026

    Report

    Report Number
    1710034-2026-00553
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826230
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    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. THE BD 22G INSYTE AUTOGUARD IV HAS DIFFICULTY RETRACTING NEEDLE TO INITIATE SAFETY. THERE WAS NO HARM TO THE PATIENT OR CLINICIAN OTHER THAN HAVING TO RESTART THE IV. 5/20/2026: PREVIOUSLY, NONE OF THE CATHETERS WERE PIERCED BY THE NEEDLE. AS TO THE SECOND QUESTION, I AM UNABLE TO ANSWER THAT. I WAS NOT THE ONE WHO UTILIZED THE PART AND HE DOES NOT REMEMBER. WE USE SO MANY OF THESE EACH DAY. EVERYTHING DURING THE VENIPUNCTURE PROCESS WENT SMOOTHLY, THOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236711 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5343666 00382903826230

    Patients

    Seq Age Sex Outcome Treatment
    1