BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFF. NA CITRATE 0.109M, 3.2%

    MDR report key: 8599412 · Received May 10, 2019

    Report

    Report Number
    8599412
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 8, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE A LOT OF LIGHT BLUE TOP TUBES THAT ARE OVERFILLING WHICH MAKES THE BLOOD TO ANTICOAGULANT RATIO UNACCEPTABLE FOR TESTING. THE TUBES ARE LAWSON #000509 2.7 ML BLUE TOP TUBES. THE DEFECTIVE LOT NUMBER IS 830394O, EXPIRATION DATE OF 8/31/2019. I HAVE A REPORT FROM THREE DIFFERENT LOCATIONS WITH THIS LOT OF TUBES THAT ARE ALL EXPERIENCING THIS ISSUE. WE CANNOT IDENTIFY A RECALL THAT IS PLACE FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394165 BD VACUTAINER® BUFF. NA CITRATE 0.109M, 3.2% TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY 363083 830394O

    Patients

    Seq Age Sex Outcome Treatment
    1