BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 6565317 · Received May 12, 2017

    Report

    Report Number
    2084725-2017-00233
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 19, 2017
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME - THE CORRECT BRAND NAME IS STERRAD® SEALSURE CHEMICAL INDICATOR TAPE. COMMON DEVICE - THE CORRECT COMMON DEVICE IS INDICATOR, CHEMICAL. CATALOG NUMBER - THE CORRECT CATALOG NUMBER IS 14202.

    Additional Manufacturer Narrative · 1

    LOT # CORRECTION FROM 241916 TO UNKNOWN. EXP DATE: CORRECTION FROM 7/5/2018 TO UNKNOWN. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS BY LOT NUMBER, RETAINS ANALYSIS, SYSTEM RISK ANALYSIS (SRA), VISUAL ANALYSIS AND CONCOMITANT PRODUCT EVALUATION. ¿ THE DHR REVIEW, COMPLAINT TRENDING BY LOT NUMBER AND RETAINS TESTING WERE NOT PERFORMED AS THE LOT NUMBER PROVIDED WAS AN INVALID LOT NUMBER AND MULTIPLE ATTEMPTS AT FOLLOW-UP WITH THE CUSTOMER WERE UNSUCCESSFUL. ¿ THE SRA INDICATES THE RISK ASSOCIATED WITH A QUALITY PROBLEM WITH NO IMPACT ON SAFETY IS "LOW." ¿ THE PRODUCT WAS NOT RETURNED; THEREFORE, NO VISUAL ANALYSIS WAS PERFORMED. ¿ THE CONCOMITANT STERRAD 100S WAS EVALUATED AND TESTED BY AN ASP FIELD SERVICE ENGINEER (FSE). THE ISSUE WAS RESOLVED BY CALIBRATING THE BARATRON(S) AND CLEANING THE DOOR ASSEMBLY. THE COMPLETED THE CORRECTIVE MAINTENANCE AND THE UNIT MET SPECIFICATIONS AFTER THE SERVICE. THE LIKELY ASSIGNABLE CAUSE OF THE ISSUE CAN BE ATTRIBUTED THE CONCOMITANT STERRAD 100S. THE FSE COMPLETED THE CORRECTIVE MAINTENANCE ON THE UNIT AND THE ISSUE WAS RESOLVED. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE STERRAD® SEALSURE CHEMICAL INDICATOR TAPE DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD® 100S CYCLE. THE AFFECTED LOAD WAS REPROCESSED. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF STERRAD® SEALSURE CHEMICAL INDICATOR TAPE NOT CHANGING COLOR CORRECTLY. ONE-10W3K9A AND 1-10W3M45 ARE RELATED COMPLAINTS FROM THE SAME FACILITY. THIS IS TWO OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2017-00232 AND 2084725-2017-00233.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346521 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 241916

    Patients

    Seq Age Sex Outcome Treatment
    1