BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILCONTAINER PRIMELINE LID

    MDR report key: 3844700 · Received May 27, 2014

    Report

    Report Number
    3844700
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AESCULAP, INC.
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE START OF THE CASE, A MINOR INSTRUMENT TRAY WAS OPENED FOR THE PROCEDURE. THE CASE PROCEEDED. DURING THE PROCEDURE, THE CIRCULATING NURSE NOTICED THAT THE LID TO THE INSTRUMENT TRAY WAS CRACKED PUTTING STERILITY OF THE INSTRUMENTS IN QUESTION. THE STERILE INDICATORS IN THE SET SHOWED THE CONTENTS TO BE STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311798 STERILCONTAINER PRIMELINE LID STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCE KCT AESCULAP, INC. THREE-QUARTER SIZE BLUE LID *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR