BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUTAINER SPECIMEN COLLECTION ASSEMBLY W/ BLUNT PLASTIC CAN

    MDR report key: 2083301 · Received May 5, 2011

    Report

    Report Number
    2083301
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE DRAWING BLOOD FROM THE PATIENT'S ARTERIAL LINE WITH THE VACUTAINER, THE TIP OF VACUTAINER BROKE IN THE PORT OF THE ARTERIAL LINE. BLOOD CONTINUOUSLY DRAINED FROM ARTERIAL LINE AND ENTIRE LINE HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUTAINER SPECIMEN COLLECTION ASSEMBLY W/ BLUNT PLASTIC CAN VACUTAINER SPECIMEN COLLECTION JKA BECTON DICKINSON 303380 *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR