BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QBC ACCUTUBE

    MDR report key: 318978 · Received March 2, 2001

    Report

    Report Number
    1119779-2001-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2001
    Date of Event
    January 31, 2001
    Report Date
    March 1, 2001
    Manufacturer
    BECTON DICKINSON
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER CENTRIFUGING A PT'S BLOOD SPECIMEN IN THE ACCUTUBE, THE USER CHECKED TO DETERMINE IF PLUG WAS ACTUALLY SEATED BY PUSHING THE PLUG END AGAINST THE LAB COUNTER. THE TUBE BROKE. USER HAD GLASS REMOVED FROM FINGER BUT REQUIRED NO STITCHES. BECAUSE TUBE CONTAINED HUMAN BLOOD THEY ARE FOLLOWING A BLOODBORNE PATHOGEN EXPOSURE TREATMENT PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9134 QBC ACCUTUBE SAMPLE TUBE GKZ BECTON DICKINSON NA 0129760

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention