BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARQUEST MICRO A.B.G.

    MDR report key: 746784 · Received September 23, 2005

    Report

    Report Number
    MW1036703
    Event Type
    Other
    Date Received
    September 23, 2005
    Date of Event
    September 14, 2005
    Report Date
    September 23, 2005
    Manufacturer
    VITAL SIGNS COLORADO
    Product Code
    CBT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING AN ARTERIAL BLOOD GAS, THERAPIST STUCK THE RADIAL ARTERY AND THE BLOOD DID NOT ENTER THE BARREL OF THE SYRINGE. IT SPILLED OUT THE SIDE OF THE NEEDLE HUB. MANIPULATIONS OF SYRINGE AND HUB WHEN THE MALFUNCTION OCCURRED APPARENTLY RESULTED IN A SMALL HEMATOMA AT THE SITE. THERAPIST HAS YEARS OF EXPERIENCE AND FEELS THIS WAS A PRODUCT FAILURE- NOT TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUEST MICRO A.B.G. ARTERIAL BLOOD SAMPLER CBT VITAL SIGNS COLORADO MICRO ABG 7941C

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other