BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 6263814 · Received January 19, 2017

    Report

    Report Number
    2084725-2017-00030
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 29, 2016
    Report Date
    December 30, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CERTIFICATE OF CONFORMANCE WAS REVIEWED AND THE INVOLVED LOT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. THIRTY RETAIN CI STRIPS WERE STERRAD PROCESSED AND OBSERVED FOR COLOR CHANGE. ALL STRIPS MET SPECIFICATION FOR COLOR CHANGE.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING OF LOT NUMBER, RETAINS ANALYSIS, VISUAL ANALYSIS, CONCOMITANT PRODUCT EVALUATION AND SYSTEM RISK ANALYSIS (SRA). TRENDING ANALYSIS BY LOT NUMBER WAS NOT REVIEWED SINCE USER ERROR WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. THE SRA INDICATES THE RISK ASSOCIATED WITH EXPOSURE TO BIOHAZARDOUS, PATHOGENIC OR INFECTIOUS MATERIAL IS "LOW." THE PRODUCT WAS NOT RETURNED SINCE USER ERROR WAS DETERMINED TO BE THE ISSUE. THE CONCOMITANT STERRAD® 100NX WAS NOT EVALUATED SINCE THERE IS SUFFICIENT INFORMATION TO DETERMINE USER ERROR. THE LIKELY ASSIGNABLE CAUSE FOR THE COLOR - CHEMICAL INDICATOR ISSUE WAS FOUND TO BE USE ERROR AS THE CHEMICAL INDICATOR (CI) STRIPS WERE PLACED INCORRECTLY IN THE CONCOMITANT STERRAD® 100NX UNIT. THE TSR PROVIDED EDUCATION TO THE CUSTOMER OVER THE PHONE ABOUT PROPER PLACEMENT OF CI STRIPS AND SENT THE CUSTOMER THE CHEMICAL INDICATOR POST-PROCESSING DOCUMENT. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    BRAND NAME - THE CORRECT BRAND NAME IS STERRAD CHEMICAL INDICATOR STRIP. COMMON DEVICE - THE CORRECT COMMON DEVICE IS INDICATOR, CHEMICAL. CATALOG NUMBER - THE CORRECT CATALOG NUMBER IS 14100_90. LOT NUMBER - THE CORRECT LOT NUMBER IS 132611-03.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A STERRAD CHEMICAL INDICATOR STRIP DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED EXPRESS CYCLE ON THE STERRAD 100NX CYCLE. THE AFFECTED LOAD WAS NOT RELEASED. 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 CHEMICAL INDICATOR STRIPS NOT CHANGING COLOR CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47230 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1