BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX REGULAR

    MDR report key: 6019289 · Received October 11, 2016

    Report

    Report Number
    2084725-2016-00595
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD, COMPLAINT TRENDING, SYSTEM RISK ANALYSIS (SRA), VISUAL ANALYSIS, FUNCTIONAL ANALYSIS AND RETAINS ANALYSIS. ¿ THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT AVAILABLE. ¿ COMPLAINT TRENDING COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. ¿ THE SRA INDICATES THE RISK ASSOCIATED WITH EXPOSURE TO BIOHAZARDOUS, PATHOGENIC OR INFECTIOUS MATERIAL IS "LOW." ¿ VISUAL ANALYSIS WAS NOT PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR RETURN. ¿ THE SUPPLIER WAS NOT NOTIFIED OF THE ISSUE AS THE ISSUE WAS NOT IDENTIFIED AS A MANUFACTURING OR FUNCTIONAL ISSUE. ¿ RETAINS TESTING WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE ASSIGNABLE CAUSE OF THIS ISSUE WAS FAILURE TO FOLLOW INSTRUCTIONS. THE CUSTOMER WAS SENT THE INSTRUCTIONS FOR USE (IFU). UPON FURTHER FOLLOW-UP, THE CUSTOMER STATED THEY ARE NO LONGER USING THE PRODUCT. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO INQUIRE ABOUT PROPER INSTRUCTIONS FOR USE (IFU) WITH THEIR CIDEX® ACTIVATED DIALDEHYDE SOLUTION. THE CUSTOMER STATED THEY HAVE BEEN SOAKING THEIR INSTRUMENTS FOR 5 MINUTES IN THE SOLUTION. THEY ALSO STATED THEY DO NOT USE TEST THEIR CIDEX® ACTIVATED DIALDEHYDE SOLUTION PRIOR TO USE. THERE WERE NO REPORTED SERIOUS INJURIES REPORTED WITH THIS EVENT. THE CUSTOMER WAS INFORMED THE CIDEX® ACTIVATED DIALDEHYDE SOLUTION MUST BE TESTED PRIOR TO EACH USE WITH CIDEX® SOLUTION TEST STRIPS, AND THE SOAKING TIME IS 45 MINUTES. THE CUSTOMER WAS ADVISED TO ALWAYS FOLLOW THE IFU. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DETERMINED THAT IN THIS SITUATION, STERILITY OR HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THEREFORE ASP HAS DECIDED TO REPORT ALL INCIDENTS AS A MATTER OF POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668883 CIDEX REGULAR BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1