BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADD A CATH FOLEY TRAY

    MDR report key: 1416578 · Received March 30, 2009

    Report

    Report Number
    9612030-2009-00009
    Event Type
    Other
    Date Received
    March 30, 2009
    Date of Event
    February 20, 2009
    Report Date
    March 5, 2009
    Manufacturer
    COVIDIEN
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 3/05/2009 THAT A CUSTOMER HAD A PROBLEM WITH A UROLOGY TRAY. THE CUSTOMER REPORTS THAT THE USER WAS STUCK WITH A 3.5" UNSHEATHED COMPETITOR NEEDLE THAT WAS FOUND INSIDE SEALED TRAY, FOLDED UNDER THE THUMB OF THE GLOVE. CUSTOMER REPORTS HOSPITAL PROTOCOL FOLLOWED FOR CONTAMINATED NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD A CATH FOLEY TRAY FOLEY TRAY NWR COVIDIEN 5029 823152764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK