BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 2243649 · Received July 27, 2011

    Report

    Report Number
    1710034-2011-00066
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED (B)(4) 2011 AND SENT FOR DECONTAMINATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CLINICIAN PLACED THE NEEDLE AND HAD GOOD BLOOD RETURN. SHE THEN PUSHED THE BUTTON AND IT STAYED IN THE DOWN POSITION AND WOULD NOT RETRACT THE NEEDLE. SHE TRIED TO PUSH THE BUTTON AGAIN BUT THERE WAS NO GIVE IN THE BUTTON, IT STAYED IN THE DOWN POSITION. THE CLINICIAN THEN PLACED HER LEFT HAND ON THE CATHETER/HUB PORTION AND THE NEEDLE COMPLETELY PULLED OUT OF THE HUB. THERE WAS NO HARM TO THE PATIENT, ALTHOUGH HE DID NEED TO BE STUCK AGAIN.

    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 1060360

    Patients

    Seq Age Sex Outcome Treatment
    1