BEUDAMED
    FDA Adverse Event Other Summary report: N

    KWIK-KIT

    MDR report key: 687590 · Received February 15, 2006

    Report

    Report Number
    687590
    Event Type
    Other
    Date Received
    February 15, 2006
    Date of Event
    January 30, 2006
    Report Date
    February 15, 2006
    Manufacturer
    KENDALL-LTP, A DIVISION OF TYCO HEALTHCARE
    Product Code
    FSM
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILE BASIN SET OPENED PRE-OPERATIVELY AND IMMEDIATELY BIOBURDEN WAS NOTED ON THE INNER BASIN. THE BASIN SET WAS TAKEN OUT OF THE STERILE FIELD. NO OTHER PARTS OF THE STERILE FIELD WERE CONTAMINATED BY THE BASIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KWIK-KIT KIT, BASIN FSM KENDALL-LTP, A DIVISION OF TYCO HEALTHCARE * 5343399

    Patients

    Seq Age Sex Outcome Treatment
    1 *