BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 6263824 · Received January 19, 2017

    Report

    Report Number
    2084725-2017-00032
    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

    PER THE CERTIFICATE OF CONFORMANCE, THE INVOLVED LOT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. NO ANOMALIES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE CUSTOMER'S EXPERIENCED ISSUE.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE BATCH RECORD, SYSTEM RISK ANALYSIS (SRA) REVIEW. LOT TRENDING, RETAINS TESTING, PRODUCT RETURN EVALUATION/VISUAL ANALYSIS AND CONCOMITANT PRODUCT EVALUATION WERE NOT PERFORMED AS THERE IS SUFFICIENT INFORMATION TO DETERMINE USER ERROR AS THE CAUSE OF THE ISSUE. DEVICE BATCH RECORD INDICATES TEST SPECIFICATIONS FOR PRODUCT RELEASE WERE MET. NO ISSUES WERE OBSERVED IN THE RELEASE RECORD THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT. THE SRA INDICATES THE RISK ASSOCIATED WITH A QUALITY PROBLEM WITH NO IMPACT ON SAFETY IS "LOW." THE ASSIGNABLE CAUSE OF THE ISSUE CAN BE ATTRIBUTED TO USER ERROR AS THE CHEMICAL INDICATOR (CI) STRIPS WERE PLACED INCORRECTLY IN THE CONCOMITANT STERRAD® 100NX UNIT. THE CUSTOMER STATED THE CI STRIPS WERE BEING STORED INSIDE A POUCH UNDERNEATH A LOADED TRAY. THE ASP TECHNICAL SUPPORT REPRESENTATIVE PROVIDED INSTRUCTIONS OVER THE PHONE TO THE CUSTOMER AND A LETTER WAS SENT WITH THE INSTRUCTIONS FOR USE (IFU) IN REGARDS TO PROPER LOAD PLACEMENT. THIS 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
    47468 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1