BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX, DENVER BIOMEDICAL

    MDR report key: 1029657 · Received April 14, 2008

    Report

    Report Number
    MW5006265
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED PROBLEM WITH SUCTION BOTTLE OF PLEURX CATHETER-DENVER BIOMEDICAL AND PLEURX ARE REGISTERED TRADEMARKS OF CARDINAL HEALTH, INC OR ONE IF ITS SUBSIDIARIES- SUCTION DEVICE DEFECTIVE-NO SUCTION. OVER THE PAST COUPLE OF WEEKS IT HAS NOW BEEN REPORTED THAT THE SPONGE IN THE KIT, WHICH IS PART OF THE DRESSING, IS VISIBLY CONTAMINATED. THEY ARE IN 2 DIFFERENT LOT NUMBERS AS INDICATED IN THIS REPORT. NURSES HAVE NOTED PRIOR TO APPLICATION TO THE PT-NO ADVERSE EVENT OCCURRED TO THE PTS. DATES OF USE: 14 DAYS IN 2008. DIAGNOSIS OR REASON FOR USE:PLEURAL EFFUSION, LUNG CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX, DENVER BIOMEDICAL DRESSING SPONGE WITHIN KIT KDQ CARDINAL HEALTH SPONGE WITHIN KIT D07091321
    2 PLEURX, DENVER BIOMEDICAL DRESSING SPONGE WITHIN KIT KDQ CARDINAL HEALTH SPONGE WITHIN KIT D07091328

    Patients

    Seq Age Sex Outcome Treatment
    1 *