BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18046440 · Received November 1, 2023

    Report

    Report Number
    18046440
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 9, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: I WAS USING BD INSYTE AUTOGUARD BC 20GA X 1.16 IN IV INSERTION CATHETER/NEEDLE. I COULD NOT PENETRATE THE SKIN WITH THE NEEDLE/CATHETER. I STOPPED MY ATTEMPT AND NOTED THAT THE PLASTIC CATHETER WAS NOT SMOOTH AT THE TIP. IT HAD A RIDGE PREVENTING ME FROM INSERTING THE NEEDLE CATHETER. LOT# 3192266, EXP [REDACTED DATE], (B)(4), MANUFACTURED DATE [REDACTED DATE], REF 382534.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142777 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 382534 3192266

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA Male