BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 1715238 · Received June 9, 2010

    Report

    Report Number
    2084725-2010-00202
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K924434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: SCOPE - PART AND SERIAL #S - UNKNOWN. OLYMPUS DSD SCOPE WASHER - PART AND SERIAL #S UNKNOWN. (B)(4) NO CODE AVAILABLE: DISINFECTANT SPILL

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, BATCH RECORD REVIEW AND FAILURE MODE EFFECTS ANALYSIS. COMPLAINT HISTORY TRENDING FOR CIDEX ACTIVATED DIALDEHYDE SOLUTION WAS PERFORMED AND FOUND THERE IS NOT A SIGNIFICANT TREND FOR CIDEX SOLUTION SPILL. BATCH RECORD REVIEW OF CIDEX ACTIVATED DIALDEHYDE SOLUTION COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) SCORE IS BELOW THE THRESHOLD RELATING TO THE ISSUE OF CIDEX SOLUTION SPILL. THERE WAS NO PRODUCT SAMPLE RETURNED FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW. THE ROOT CAUSE OF THIS REPORT IS CONFIRMED AN ACCIDENTAL SPILL AT THE FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CIDEX SPILL WHICH OCCURRED WHEN A SCOPE WAS PLACED IN THE OLYMPUS DSD SCOPE WASHER INCORRECTLY AND THE SOLUTION SPILLED OUT OF THE LID. THE SPILL WAS CLEANED UP. AN ASP ASSOCIATE REVIEWED THE MSDS WITH THE CALLER. THERE WAS NO CONTACT WITH THE SPILL AND THERE WERE NO HUMAN REACTIONS DUE TO THE SPILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX ACTIVATED DIALDEHYDE SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1