BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTYLE AUTOGUARD IV CATH

    MDR report key: 364088 · Received December 4, 2001

    Report

    Report Number
    MW1023516
    Event Type
    Injury
    Date Received
    December 4, 2001
    Date of Event
    August 26, 2001
    Report Date
    November 20, 2001
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    2001 #24 QA IV INSERTED RIGHT LOWER ARM WITH 3% NACL AT 20/HR. TWO DAYS LATER IV INFILTRATED AND RESTART 2ND HAD. TWO DAYS C/O PAIN RIGHT LOWER ARM WAS HARD, SWOLLEN, NO REDNESS. THE NEXT DAY RIGHT FOREARM PAIN, SWOLLEN AND PLUS REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54530 INSTYLE AUTOGUARD IV CATH IV INFUSION CATHETER FOZ BECTON DICKINSON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R