BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEAM STER LOCKS ORANGE

    MDR report key: 5818144 · Received July 23, 2016

    Report

    Report Number
    2916714-2016-00618
    Event Type
    Malfunction
    Date Received
    July 23, 2016
    Date of Event
    June 1, 2016
    Report Date
    April 13, 2020
    Manufacturer
    AESCULAP INC
    Product Code
    KCT
    PMA / PMN Number
    K944864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A RETROSPECTIVE REVIEW OF POTENTIAL SERIOUS INJURY COMPLAINTS WAS PERFORMED. THIS MDR WAS IDENTIFIED AND FILED AS PART OF THE REVIEW ACTIVITIES. B5: CLARIFICATION ADDED. THE COMPLAINED PRODUCT WAS NOT RETURNED AND THE BATCH # WAS NOT PROVIDED. DUE TO THE TIME FRAME, IT WAS REASONABLE TO ASSUME THAT THE PRODUCT FELL WITHIN THE SCOPE OF THE DESCRIPTION NOTED BELOW. SUPPLIER: (B)(4). ACTIONS TAKEN: CAPA OPENED BY AESCULAP INC. CORRECTIVE ACTION: SPS- IN OCTOBER 2016, A LABELING CHANGE HAD BEEN MADE TO STATE THAT THIS PRODUCT SHOULD BE KEPT OUT OF DIRECT SUNLIGHT, AWAY FROM HEAT SOURCES, AWAY FROM HYDROGEN PEROXIDE, AND OTHER STERILANTS. DESCRIPTION: THERE WERE AN INCREASED NUMBER OF COMPLAINTS ON THE INDICATOR DOT LABELS REVERTING BACK TO BLUE OR NOT FULLY TURNING. THE SUPPLIER WAS MADE AWARE OF THE COMPLAINTS AND VARIOUS LOTS WERE INVESTIGATED. DURING THE INVESTIGATION, INK MANUFACTURING PROCESS WAS REVIEWED AND VERIFIED. NO CHANGES, OTHER THAN GOING TO A LEAD-FREE INK WERE MADE IN THE PROCESS OR TO THE RAW MATERIALS ASSOCIATED WITH MAKING THIS PRODUCT. ADDITIONALLY, A COMPREHENSIVE REVIEW WAS CONDUCTED WITH THE INK MANUFACTURER ON THE CHEMICAL MAKEUP OF THE INK. NO CHANGES WERE MADE OR FOUND. LASTLY, MULTIPLE TESTS AND STUDIES WERE CONDUCTED IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE OF THE ISSUES BEING REPORTED BY CUSTOMERS. CONCLUSION: AT THIS TIME THE ISSUES OF REVERSION AND INCONSISTENT COLOR CHANGE WERE ABLE TO BE DUPLICATED. THROUGH TESTING IT WAS FOUND THAT BOTH LEAD AND LEAD-FREE INDICATOR LABELS WOULD BE ADVERSELY AFFECTED BY BEING EXPOSED TO HYDROGEN PEROXIDE POST-STERILIZATION. IN ALL TEST CASES, A REVERSION WOULD OCCUR ONCE THE PROCESSED LABEL WAS EXPOSED TO HYDROGEN PEROXIDE. THE LEAD-FREE INDICATOR LABELS WERE ADVERSELY AFFECTED BY THE EXPOSURE TO DIRECT SUNLIGHT AND HYDROGEN PEROXIDE. IN HYDROGEN PEROXIDE EXPOSURE PRIOR TO STERILIZATION, AN INCONSISTENT COLOR CHANGE WAS EXPERIENCED AND LED TO A REVERSION OVER THE COURSE OF TESTING. ADDITIONALLY, EXPOSURE TO DIRECT SUNLIGHT HAS CAUSED THE INDICATOR LABEL TO REVERT AND FLUORESCENT LIGHT HAS BEGUN TO FADE THESE INDICATOR LABELS. LEAD INDICATOR LABELS WERE NOT AS SENSITIVE TO THESE EXPOSURE TYPES BUT DID SHOW SIGNS THAT THESE EXPOSURES AFFECTED THE PRODUCT. DURING PRE-STERILIZATION HYDROGEN PEROXIDE EXPOSURE, IT WAS FOUND THAT THE LEAD INDICATOR LABELS DISPLAYED AN INCONSISTENT COLOR CHANGE. BOTH DIRECT SUNLIGHT AND FLUORESCENT LIGHT DID NOT APPEAR TO ADVERSELY AFFECT THE PRODUCT. CORRECTIVE ACTION: SEE ABOVE.

    Description of Event or Problem · 0

    CLARIFICATION WAS RECEIVED: THERE WERE DELAYS IN THE START OF SURGERIES WHILE STAFF LOCATED REPLACEMENT TRAYS. SOME PATIENTS WERE ALREADY UNDER ANESTHESIA; OTHER THAN ADDITIONAL ANESTHESIA TIME, THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE INVESTIGATION IS ON-GOING. (B)(4).

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: USA. CUSTOMER REPORTED THAT IN THE CENTRAL STERILE PROCESSING AREA IT WAS OBSERVED THAT THE ORANGE LOCKS DOTS ARE: TURNING BACK TO BLUE AFTER STERILIZED; (OR) ONLY PARTIALLY TURNING BROWN/BLACK; (AND) THE INK SEEMS TO BE COMING OFF THE INDICATOR DOTS. THE CUSTOMER STATED THAT THIS CAUSED A DELAY IN SURGERY FOR MAYBE AN HOUR BECAUSE THEY HAD TO REPROCESS SETS AGAIN. THEY REPORTED THAT THEY DID HAVE PATIENTS UNDER ANESTHESIA THAT HAD TO REMAIN UNDER ADDITIONAL ANESTHESIA WHILE NEW TRAYS WERE LOCATED OR THE TRAYS WERE RE-STERILIZED USING IUSS. THE CUSTOMER CONFIRMED THAT OTHER THAN ADDITIONAL ANESTHESIA AND OR TIME THERE WERE NO ADDITIONAL INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470991 STEAM STER LOCKS ORANGE PROCESS INDICATOR LOCK KCT AESCULAP INC US906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other