BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 2150498 · Received June 23, 2011

    Report

    Report Number
    1710034-2011-00052
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION REGARDING THIS INCIDENT HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CATHETER TUBING BROKE AWAY FROM THE YELLOW PLASTIC ADAPTER DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 0343177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other