BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIC070 956-518

    MDR report key: 660959 · Received September 15, 2005

    Report

    Report Number
    3002807968-2004-00015
    Event Type
    Other
    Date Received
    September 15, 2005
    Date of Event
    May 1, 2003
    Report Date
    December 10, 2004
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CBT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE USED BLOOD SAMPLER (SYRINGE) SUPPLIED WITHOUT NEEDLE AND PUT A THIRD PARTY NEEDLE ON THE SYRINGE TO DRAW BLOOD. BECAUSE THE SYRINGE WAS SUPPLIED WITHOUT A NEEDLE THE LABELING DID NOT INCLUDE INSTRUCTIONS ON HOW TO USE A SAFETY DEVICE WHICH IS NONETHELESS SUPPLIED WITH THE SYRINGE. THE USER SUSTAINED A NEEDLE STICK WHILE ATTEMPTING TO INSERT THE NEEDLE IN THE SAFETY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC070 956-518 BLOOD SAMPLER CBT RADIOMETER MEDICAL APS PICO70 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other