BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESP CONNECTOR

    MDR report key: 304327 · Received November 6, 2000

    Report

    Report Number
    2183729-2000-00001
    Event Type
    Malfunction
    Date Received
    November 6, 2000
    Date of Event
    October 18, 2000
    Report Date
    October 18, 2000
    Manufacturer
    TREK DIAGNOSTICS SYSTEMS, INC.
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LIQUID FROM A POSITIVE BLOOD CULTURE BOTTLE EXPLODED THROUGH TOP OF CONNECTOR AS THE LAB TECH WAS CARRYING IT TO A COUNTER. THE LIQUID SPRAYED OVER THE COUNTER, FLOOR, AND CHAIRS. THE AREA HAD TO BE DECONTAMINATED. IT APPEARS THE MEMBRANE IN THE CONNECTOR FAILED. THE ORGANISM WAS IDENTIFIED AS CLOSTRIDIUM PERFRINGES. THE BOTTLE WENT POSITIVE AT 31.4 HOURS AND WAS REMOVED AT 45.0 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESP CONNECTOR ESP CONNECTOR JTA TREK DIAGNOSTICS SYSTEMS, INC. NA H3014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other