BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 2142286 · Received June 17, 2011

    Report

    Report Number
    1710034-2011-00050
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). DATE SUBMITTED: (B)(4) 2011.

    Description of Event or Problem · 1

    AFTER THE NEEDLE WAS INSERTED AND THE CATHETER PLACED, THE CLINICIAN ATTEMPTED TO DRAW BLOOD WITH A SYRINGE AND OBSERVED THAT AIR WAS INTRODUCED. THE CLINICIAN CHANGED THE SYRINGE AND ATTEMPTED THE DRAW AGAIN, BUT THE SITUATION REMAINED THE SAME. THE CATHETER WAS REMOVED AND A NEW UNIT PLACED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other