BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIAVALVE SAFETY IV CATHETER

    MDR report key: 3173385 · Received May 29, 2013

    Report

    Report Number
    3173385
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 20 GAUGE 1 INCH IV CATHETER WAS PLACED IN THE RIGHT ACCESSORY CEPHALIC VEIN OF THE PT ON (B)(6) 2013. ON (B)(6), AFTER THE PT HAD BEEN AMBULATING WITH A WALKER, SHE REPORTED TO A NURSE THAT IV WAS BLEEDING. THE IV SITE WAS ASSESSED AND UPON REMOVAL OF THE IV CATHETER, THE NURSE NOTED THAT THE CANNULA WAS ABSENT FROM THE CATHETER HUB. X-RAY AND ULTRA SOUND IMAGING CONFIRMED A RETAINED FOREIGN BODY (IV CANNULA) IN THE VEIN. THE PT WAS TAKEN TO THE OPERATING ROOM WHERE SHE REQUIRED SURGICAL INTERVENTION TO SUCCESSFULLY REMOVE THE CANNULA. ALTHOUGH LOT NUMBERS ARE NOT RECORDED AT THE TIME OF IV INSERTION, THE LOT NUMBER PROVIDED IN THIS REPORT WAS THE PREDOMINATE LOT AVAILABLE ON THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236104 VIAVALVE SAFETY IV CATHETER IV CATHETER FOZ SMITHS MEDICAL ASD, INC 3267 ST2383712

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention