BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25069958 · Received May 4, 2026

    Report

    Report Number
    1710034-2026-00490
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    SEE H.11
    Adverse Event
    Yes
    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

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, IL WAS USED AS THE STATE.

    Additional Manufacturer Narrative · 0

    ANNEX F CODE UPDATED. IT IS UNCLEAR IF RETAINED OBJECT OCCURRED, WILL LEAVE SI DESIGNATION BASED ON POTENTIAL, THOUGH NOW UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER BROKE OR SEPARATED FROM THE HUB. THIS RN WAS PERFORMING A PERIPHERAL INTRAVENOUS INSERTION ON THE PATIENT; THE RN ATTEMPTED THE PIV IN THE PATIENTS RIGHT ANTECUBITAL AREA OF THE ARM. THIS RN INSERTED THE IV AND WAS ABLE TO OBTAIN BLOOD FOR BLOODWORK, UPON FLUSHING THE VEIN INFILTRATED. THIS RN THEN REMOVED THE PIV FROM THE PATIENTS ARM, UPON REMOVAL THIS RN HEARD A POPPING SOUND AS THE DISTAL END OF THE CATHETER WAS BEING REMOVED FROM THE PATIENTS ARM. THIS RN CALLED THE ED MD. MD TO BEDSIDE TO ASSESS PATIENT AND CATHETER THAT WAS REMOVED WITH RN. UPON ASSESSMENT THE CATHETER APPEARED TO LOOK SHORTER THAN A NEW IV CATHETER, AND THERE WAS A FIRM OBJECT FELT DIRECTLY UNDER THE SKIN AT INSERTION SITE. THIS RN APPLIED AN ARM BOARD TO PATIENT ARM SO THAT IT WOULD BE IMMOBILE AND APPLIED ICE TO ARM PER VASCULAR SURGERY. THIS RN NOTIFIED THE ED CHARGE NURSE AND HOUSE SUPERVISOR. AND DR.CALLED VASCULAR SURGERY FOR FURTHER INSTRUCTION. THE INSYTE CATHETER THAT WAS USED AND BROKE OFF WAS SAVED AND PUT IN A BAG WITH A PATIENT LABEL TO BE SENT TO PATHOLOGY FOR FURTHER STUDIES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION 05/03/2026: WAS THE CATHETER SURGICALLY REMOVED FROM PATIENT'S ARM? NO, AN ULTRASOUND WAS DONE AND NO CATHETER WAS OBSERVED. WHAT DIAGNOSTICS WERE DONE TO CONFIRM FOREIGN BODY? ULTRASOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627120 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5323615 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1