BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD SHIELDED

    MDR report key: 1820016 · Received August 18, 2010

    Report

    Report Number
    1820016
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BD MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO OUTPATIENT ONCOLOGY DEPARTMENT FOR HER CHEMOTHERAPY APPOINTMENT. ONCOLOGY RN WAS ATTEMPTING TO PLACE A 22 GAUGE IV CATHETER BUT COULD NOT GET IT TO THREAD APPROPRIATELY. REPORTS SHE INITIALLY HAD A NICE FLASH HOWEVER WHEN ATTEMPTING TO ADVANCE THE IV CATHETER IT WOULD NOT ADVANCE. RN REMOVED THE NEEDLE SYSTEM FROM THE PATIENT AND NOTICED THE PLASTIC CATHETER (WHICH ENCASES THE NEEDLE) APPEARED TO BE SPLIT INTO A "Y" SHAPE. THE METAL GUIDE WAS STILL OUT AND THE PLASTIC CATHETER WAS OFF TO THE SIDE FORMING THE "Y". IT APPEARS THE NEEDLE MAY HAVE PUNCTURED THROUGH THE PLASTIC CATHETER MAKING IT IMPOSSIBLE FOR THE CATHETER TO THREAD APPROPRIATELY. PATIENT DID COMPLAIN OF PAIN INITIALLY DURING THIS INSERTION BUT THE PAIN SUBSIDED AFTER THE NEEDLE WAS REMOVED. RN SEQUESTERED THE NEEDLE AND CATHETER AND WAS ABLE TO SUCCESSFULLY PLACE ANOTHER IV TO ADMINISTER THE PATIENTS CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD SHIELDED IV CATHETER FOZ BD MEDICAL * 0140438

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR CHEMOTHERAPY