BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 2003102 · Received February 3, 2011

    Report

    Report Number
    1710034-2011-00006
    Event Type
    Other
    Date Received
    February 3, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. THE SAMPLE HAS BEEN RECEIVED AND IS CURRENTLY BEING DECONTAMINATED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED IN THE LOWER PORTION OF THE FOREARM. THE PT WAS NOT RESTLESS. AS THE NURSE PLACED THE CATHETER, SHE NOTICED THE NEEDLE FELT BLUNT. AFTER THE NEEDLE WAS INSERTED, THE NURSE ATTEMPTED TO RETRACT THE NEEDLE. THE NEEDLE SEEMED TO HESITATE IN RETRACTING INTO THE SAFETY BARREL. AS THE NURSE PULLED BACK, SHE NOTICED THE NEEDLE TIP APPEARED TO BE BLUNT. WHEN THE NEEDLE FINALLY RETRACTED INTO THE SAFETY BARREL, THE NURSE LOOKED AT THE DEVICE TO SEE IF THERE WAS NOTICEABLE DAMAGE ON THE NEEDLE, BUT COULD NOT SEE ANYTHING. THE PT WAS SENT TO RADIOLOGY FOR AN X-RAY AS A PRECAUTIONARY MEASURE TO MAKE SURE THE NEEDLE TIP WAS NOT IN THE PT'S VEIN. RADIOLOGY FOUND AN OBJECT IN THE PT'S FOREARM, BUT COULD NOT CONFIRM WHAT IT WAS. RADIOLOGY THEN SENT THE PT TO THE EMERGENCY ROOM TO HAVE THE OBJECT REMOVED. THE EMERGENCY ROOM COULD NOT FIND ANYTHING, SO THE PT WAS SENT BACK TO RADIOLOGY TO HAVE ANOTHER X-RAY. IN THE SECOND X-RAY, THE OBJECT WAS NOT FOUND.

    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 55 YR Other