BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE AUTOGUARD IV

    MDR report key: 364093 · Received December 4, 2001

    Report

    Report Number
    MW1023517
    Event Type
    Injury
    Date Received
    December 4, 2001
    Report Date
    November 20, 2001
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    2001 #18 INSERTED LEFT UPPER FOREARM. THREE DAYS LATER IV DISCONTINUED. BLOOD CULTURES POSITIVE STAPH EPIDERMIDIS. BETA LACTOMOSE NEG (SEPTIC PHLEBITIS). THE NEXT DAY TEMP INCREASED TO 104. BLOOD CULTURES NEGATIVE. IVS - D5LR WITH 20 KCL, D5NS WITH 30 KCL, MGS04/100 D5W, TPN (IVATIVAN); UNABLE TO MATCH LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54548 INSYTE AUTOGUARD IV IV INFUSION CATHETER FOZ BECTON DICKINSON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention