BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 15679412 · Received October 27, 2022

    Report

    Report Number
    15679412
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 11, 2022
    Report Date
    October 14, 2022
    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

    NARRATIVE FROM STAFF: THE SHEATH OF IV HAD BEEN SHEARED BY THE NEEDLE BEFORE PLACEMENT. THE IV PLACEMENT WAS ATTEMPTED... ONCE THE SKIN AND VEIN WERE PIERCED WITH THE NEEDLE, STAFF WERE UNABLE TO THREAD CATHETER AND REALIZED THE NEEDLE HAD COME OUT THROUGH PART OF THE CATHETER AND THAT WAS WHY THEY COULD NOT THREAD CATHETER. THE SHEATH WAS SHEARED APPROX. 1 MM FROM END. STAFF IMMEDIATELY REMOVED NEEDLE AND PLACED PRESSURE ON SITE WITH 2X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385263 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 382523 2146301

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA Female