BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19990316 · Received August 15, 2024

    Report

    Report Number
    19990316
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 26, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BD INSYTE AUTOGUARD WINGED 18G IV CATH "DULL", DOES NOT PENETRATE WELL, REQUIRING MORE FORCE CAUSING HEMATOMA AT INSERTION SITE. THE EXTRA FORCE CAUSING A HEMATOMA AT THE INJECTION SITE. TWO SEPARATE ANGIOCATHS ATTEMPTED WITH SAME RESULT. #1 LOT 3192241. #2 LOT 4127717.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176689 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 3192241, 4127717

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other