BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESOURCE

    MDR report key: 2771324 · Received August 27, 2012

    Report

    Report Number
    2771324
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 27, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR A LOWER EXTREMITY ARTERIOGRAM TO BE PERFORMED IN INTERVENTIONAL RADIOLOGY. THE PRESSURE TUBING WAS CONNECTED ON THE PROXIMAL END TO THE PRESSURE INJECTOR WHILE THE DISTAL END WAS CONNECTED TO THE DIAGNOSTIC CATHETER. THE PRESSURE INJECTOR WAS SET FOR 1200 PSI (CONFIRMED WITH VENDOR THAT PRESSURE TUBING IS RATED FOR 1200 PSI) AND WITH THE INJECTION, THE DISTAL PORTION OF THE TUBING BROKE-FREE CAUSING CONTRAST TO SPRAY THE STERILE DRAPE AND THE IMAGING EQUIPMENT. NEITHER THE PATIENT NOR THE STAFF WERE EXPOSED TO THE CONTRAST SPRAY. THE PRESSURE TUBING IS PACKAGED IN A "NAVILYST MEDICAL, NAMIC CONVERSION KIT" WHICH IN INCLUDED IN A CUSTOM PACK FOR INTERVENTIONAL RADIOLOGY. THERE ARE FIVE POTENTIAL LOT NUMBERS (4406508, 4359110, 4406508, 4359110, 4402114) THAT MAY BE INVOLVED. THE SPECIFIC PACKAGING FOR THE CONVERSION KIT WAS NOT RETAINED, HOWEVER THE CUSTOM PACK INFORMATION WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESOURCE SURGICAL PACK, VASCULAR, CUSTOM LRO CARDINAL HEALTH STRL VASCULAR PACK (CUSTOM) *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR