BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTMASTER III SYSTEM TRAY

    MDR report key: 5021938 · Received August 21, 2015

    Report

    Report Number
    1219602-2015-00889
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KCT
    PMA / PMN Number
    K092551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A PHYSICAL EXAMINATION OF THE RETURNED PRODUCT WAS CONDUCTED AND THE PRESENCE OF DISCOLORATION WAS CONFIRMED. PICTURES HAVE BEEN INCLUDED IN THE ATTACHED REPORT. AN ONSITE VISIT WAS PERFORMED AT THE WOMEN¿S COLLEGE HOSPITAL, TORONTO AND THE STERILIZATION SERVICE PROVIDER STERI-PRO. THE ON-SITE INVESTIGATION IDENTIFIED THAT THE DEVICES WERE NOT STERILIZED AND PROCESSED PER THE INSTRUCTIONS PROVIDED WITH THE DEVICE INSTRUMENTATION. THE FOLLOWING ISSUES WERE IDENTIFIED: IT WAS CONFIRMED THAT THE DEVICES WERE ONLY RECEIVING A 40 MINUTE DRY TIME, WHICH IS 20 MINS LESS THAT THE TIME SPECIFIED IN THE IFU, AND A TRAY LINER IS USED BY STERI-PRO TO PROCESS THESE TRAYS AND APPEARS TO BE TRAPPING MOISTURE AND NOT ALLOWING THE TRAYS TO DRY PROPERLY. THE ROOT CAUSE CAN BE ATTRIBUTED TO FAILURE TO FOLLOW THE IFU AND IMPROPER MAINTENANCE - CLEANING. DURING THE ONSITE VISIT A COPY OF THE IFU WAS PROVIDED TO THE FACILITY. NO FURTHER ACTION IS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING A STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES, THAT RUST WAS ON DEVICES. CASES WERE CANCELLED DUE TO A HIGH STANDARD AND LOW TOLERANCE FOR BROWN STAINING AND LABELING ISSUES, BUT NOT CONFIRMED IF SMITH+NEPHEW DEVICES WERE BEING UTILIZED IN EACH CASE THAT WAS CANCELLED. IT WAS ALSO REPORTED AND CONFIRMED THAT THAT PATIENTS WERE IN THE OR UNDER ANESTHESIA. A THIRD PARTY WAS BROUGHT IN TO DETERMINE WHAT THE ROOT CAUSE FOR THE SPOTTING AND OXIDATION WAS, IT WAS DETERMINED THAT THE STERILIZATION PROVIDER STERIPRO WAS NOT ALLOWING THE TRAYS TO COOL PROPERLY CAUSING THE TRAYS TO SWEAT DURING TRANSPORT TO THIS FACILITY WHICH RESULTED IN THE SPOTTING AND OXIDATION OF THE TRAYS AND THEIR CONTENTS. EMAIL FROM SALES REP CONFIRMED NO CASES WERE CANCELLED DUE TO SMITH AND NEPHEW PRODUCT, PATIENT ANESTHETIZED OR OTHERWISE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555215 GRAFTMASTER III SYSTEM TRAY STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES KCT SMITH & NEPHEW, INC. 028846

    Patients

    Seq Age Sex Outcome Treatment
    1