BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL PORT-A-CUL

    MDR report key: 3812009 · Received May 8, 2014

    Report

    Report Number
    3812009
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    JTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE JAR WAS SEALED AND IN STILL IN THE PACKAGE WHEN IT WAS NOTED THAT THERE WAS A DISCOLORATION OF THE LIQUID AND THAT THERE WAS A FLOATING OBJECT IN THE JAR. THE JAR WAS NOT OPENED. THERE WAS NO PATIENT HARM IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279860 BBL PORT-A-CUL TRANSPORT SYSTEMS, ANAEROBIC JTX BECTON DICKINSON 8216020JAA (0903) 3305487

    Patients

    Seq Age Sex Outcome Treatment
    1 *