BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PERITONEAL CATH KIT

    MDR report key: 1040411 · Received May 7, 2008

    Report

    Report Number
    1423507-2008-00042
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 7, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY NO COMPLAINT SAMPLE WAS PROVIDED FOR EVAL, AND THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE ISSUE REPORTED. A REVIEW OF APPLICABLE DOCUMENTATION COULD NOT BE PERFORMED SINCE NO LOT INFO WAS PROVIDED WITH THE COMPLAINT REPORT. THEREFORE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    HOSP HAS REPORTED THAT THEIR LAST TWO CATHETERS THAT WERE PLACED, THE PT REPORTEDLY DEVELOPED AN INFECTION AFTER 2-3 MONTHS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PERITONEAL CATH KIT PLEURX PERITONEAL CATH KIT FJS CARDINAL HEALTH 50-9000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK