BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1804432 · Received July 28, 2010

    Report

    Report Number
    1804432
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 14, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A PORT WAS PLACED IN THE PATIENT. AFTER COMPLETION, IT WAS NOTICED THAT THE PRODUCT HAD EXPIRED. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================EXPIRATION DATE WAS WRITTEN "2009-10". SUGGESTION - WRITE EXPIRATION WITH MONTH SPELLED OUT, AND YEAR, I.E. OCTOBER 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, IMPLANTED, PORT LJT BARD ACCESS SYSTEMS 1806061 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR