BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD

    MDR report key: 1040325 · Received May 7, 2008

    Report

    Report Number
    MW5006776
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 7, 2008
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    UPON INSERTION OF BD INSYTE CATHETER, RN ACTIVATED SPRING LOADED SAFETY MECHANISM AND DISCOVERED SHE ONLY HAD THE GREEN HUB OF THE CATHETER REMAINING IN HER FINGERS. THE HUB AND THE CATHETER HAD SEPARATED. IT WAS MISTAKENLY BELIEVED THAT THE 1 INCH PORTION OF THE CATHETER WAS IN THE PATIENT'S VEIN AND IMMEDIATE INTERVENTION TO SEARCH FOR THIS PORTION WAS INITIATED. A CUT DOWN PROCEDURE WAS PERFORMED BY THE PHYSICIAN AS WELL AS ULTRASOUND AND XRAYS DONE. AN INFLATED BLOOD PRESSURE CUFF WAS MAINTAINED FOR THE DURATION OF THESE PROCEDURES. UPON FAILURE TO FIND THE MISSING PORTION OF THE CATHETER, ALL EQUIPMENT GATHERED UP, FAMILY AND PATIENT GIVEN EXPLANATIONS AS TO WHAT WAS BELIEVED TO HAVE HAPPENED AND PATIENT PROCEEDED TO BE ADMITTED FOR THE ORIGINAL MEDICAL CONDITION. RN FILLED OUT SAFETY REPORT, GATHERED ALL ITEMS AS PER POLICY AND PROCEEDED TO INFORM HER SUPERIOR. MANUFACTURER HAS BEEN NOTIFIED AND ALL PRODUCT OF THIS SPECIFIC LOT NUMBER GATHERED UP FOR REPLACEMENT BY MANUFACTURER. DATES OF USE: 2006 - 2008. DIAGNOSIS OR REASON FOR USE: IV START

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD IV CATHETER - INSYTE AUTOGUARD FOZ NA 7345737

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability