BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE

    MDR report key: 2695907 · Received August 7, 2012

    Report

    Report Number
    MW5026467
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 7, 2012
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GREINER BRAND 4ML EDTA BLOOD COLLECTION TUBES HAVE NO ANTICOAGULANT SPRAYED ON THE INSIDE OF THE TUBE RENDERING BLOOD ADDED TO THE TUBE TO CLOT UPON ENTRY TO THE TUBE. PRODUCT # IS (B)(4) IN LOT # B061205. NUMEROUS PT SAMPLES HAD TO BE REDRAWN AS SAMPLE HAD CLOTTED SOLID. DATES OF USE: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUETTE K2 EDTA JKA GREINER BIO-ONE NORTH AMERICA 4ML K2 EDTA B061205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other