BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 5324270 · Received September 17, 2004

    Report

    Report Number
    1710034-2004-00069
    Event Type
    Other
    Date Received
    September 17, 2004
    Date of Event
    August 18, 2004
    Report Date
    August 26, 2004
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER WOULD NOT RELEASE ANY MORE INFORMATION DUE TO (B)(4).

    Description of Event or Problem · 1

    THE NURSE WAS PERFORMING A VENIPUNCTURE AND PUSHED THE BUTTON ON THE DEVICE AND THE UNIT DID NOT RETRACT RESULTING IN A NEEDLE STICK INJURY TO A CO-WORKER. THIS INCIDENT OCCURRED AS A RESULT OF THE CO-WORKER HOLDING THE PT WHILE THE NURSE WAS PERFORMING THE VENIPUNCTURE. THE CO-WORKER WAS STUCK BY THE CANNULA ON THE 3RD FINGER OF THE RIGHT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other