BEUDAMED
    FDA Adverse Event Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 489724 · Received September 30, 2003

    Report

    Report Number
    MW1029695
    Date Received
    September 30, 2003
    Date of Event
    March 10, 2003
    Report Date
    September 29, 2003
    Manufacturer
    BD MEDICAL SYSTEMS
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEEDLE DULLNESS NOT ADVANCING, SKIN BUNCHING AND BLOWING VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 2353780
    10 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 2266650
    11 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 3115076
    12 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 2192456
    13 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 2192456
    14 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 3080378
    15 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 3044935
    16 * * --- * * *
    2 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 2190317
    3 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 111019
    4 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 3058834
    5 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 2199208
    6 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 3094519
    7 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 3059657
    8 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 3038645
    9 BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER FOZ BD MEDICAL SYSTEMS * 2330356

    Patients

    Seq Age Sex Outcome Treatment
    1 *