BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1971812 · Received January 13, 2011

    Report

    Report Number
    1710034-2010-00065
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAVE BEEN MADE. UPON COMPLETION OF THE NO SAMPLE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE NURSE WAS STARTING AN IV AND GOT BLOOD FLASHBACK AS APPROPRIATE. SHE PUSHED THE BUTTON TO RETRACT THE NEEDLE WHILE APPLYING PRESSURE TO THE SITE. THE NEEDLE DID NOT RETRACT AND WHEN SHE REMOVED IT FROM THE PATIENT, THE NEEDLE STUCK HER LEFT INDEX FINGER WITH WHICH SHE WAS USING TO HOLD THE PRESSURE TO THE SITE.

    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 0127421

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other