BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX

    MDR report key: 899016 · Received July 25, 2007

    Report

    Report Number
    899016
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 17, 2007
    Report Date
    July 25, 2007
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLEURX KIT WITH CATHETER WAS USED ON STERILE FIELD. THE PACKAGE WAS INTACT AND WAS WITHIN EXPIRATION DATE. AFTER THE SURGEON HAD IMPLANTED THE CATHETER INTO THE PATIENT'S CHEST THE SCRUB TECH NOTICED A DEAD BUG IN THE TRAY. SURGEON AND CHARGE NURSE WERE NOTIFIED AND BY REVIEW OF THE PACKAGING - IT IS OBVIOUS THAT THE BUG HAD BEEN ONCE ADHERED TO THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX KIT, PLEURAL CATHETER KDQ DENVER BIOMEDICAL, INC. * 9290

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR