BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIAVALVE SAFETY IV CATHETER

    MDR report key: 3162973 · Received May 9, 2013

    Report

    Report Number
    3162973
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 9, 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 BASILIC VEIN OF THE PT'S DISTAL LEFT FOREARM ON (B)(6) 2013. ON (B)(6) 2013, UPON THE NURSE'S REMOVAL OF THE IV CATHETER, THE CANNULA WAS NOTED TO BE ABSENT FROM THE CATHETER HUB. X-RAY AND ULTRASOUND IMAGES CONFIRMED THE PRESENCE OF A FOREIGN BODY, THE CANNULA, WITHIN THE BASILIC VEIN JUST PROXIMAL TO THE LEVEL OF THE WRIST. THE PT REQUIRED SURGICAL INTERVENTION TO REMOVE THE CANNULA. THE PT WAS DISCHARGED HOME AFTER RECOVERING FROM THE SURGERY AND ANESTHESIA. ALTHOUGH LOT NUMBERS ARE NOT RECORDED AT THE TIME OF IV INSERTION. ONLY THE LOT NUMBER WAS IN USE ON THE UNIT WHERE THE CATHETER WAS INSERTED. ALL CATHETERS FROM THIS LOT NUMBER WERE REMOVED FROM PT CARE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202823 VIAVALVE SAFETY IV CATHETER IV CATHETER FOZ SMITHS MEDICAL ASD, INC 3267 ST2393195

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention