BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL

    MDR report key: 1885200 · Received October 21, 2010

    Report

    Report Number
    1885200
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    OJU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    OR STAFF REPORTED THAT UPON OPENING A STERILE SCRUB CARE PREOPERATIVE SKIN PREP TRAY, MADE FOR OUR FACILITY BY CARDINAL HEALTH, IT WAS NOTED THE KIT CONTAINED A LONG, BLACK, HUMAN HAIR INSIDE. OBVIOUSLY THIS IS A STERILITY CONCERN. THE KIT WAS NOT USED FOR PROCEDURE. IT WAS SAVED AND IS AVAILABLE FOR RETURN TO THE MANUFACTURER.====================== HEALTH PROFESSIONAL'S IMPRESSION======================OBVIOUSLY THIS IS A STERILITY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL SCRUB CARE PREOPERATIVE SKIN PREP TRAY - STERILE - SINGLE US OJU CARDINAL HEALTH 4468 NEXT IN BOX Y10H2832

    Patients

    Seq Age Sex Outcome Treatment
    1 *