BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 24377023 · Received February 18, 2026

    Report

    Report Number
    24377023
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 9, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT NEEDED A PIV [PERIPHERAL INTRAVENOUS LINE] REPLACED. RN'S TRIED 4 TIMES AND NNP [NEONATAL NURSE PRACTITIONER] TRIED 3 TIMES BEFORE SUCCESSFULLY PLACING AN IV. IV'S WOULD FLASH AND THEN BLOW. MULTIPLE TIMES IT WAS DIFFICULT TO PUNCTURE THE SKIN, AS IF THE NEEDLES WERE NOT SHARP ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435619 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 381412 5277920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other