BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITUBES

    MDR report key: 3723583 · Received March 21, 2014

    Report

    Report Number
    1523456-2014-00001
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    January 19, 2014
    Report Date
    January 23, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    GIO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN THE USER (TECHNICIAN) WAS DRAWING BLOOD FROM AN INFANT THE CAPILLARY BROKE WHEN THE END CAP WAS BEING PUT ON. THE USERS LEFT MIDDLE FINGER WAS PUNCTURED. GLOVES WERE WORN. THE REPORT STATES THAT THE USER WAS TREATED AND RELEASED FROM THE ED AND SENT HOME. NO SPECIFIC INFORMATION REGARDING THE TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169118 CLINITUBES GLASS CAPILLARY TUBES GIO RADIOMETER MEDICAL APS D957G-70-125 JV02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other