BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 1363322 · Received January 16, 2009

    Report

    Report Number
    2084725-2009-00025
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 30, 2008
    Report Date
    December 30, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K924434
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE GI SCOPES WERE SOAKED FOR ONLY FIVE MINUTES IN THE 14-DAY CIDEX. THE SCOPES WERE REPORTED TO HAVE BEEN USED ON MULTIPLE PTS. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. AN ASP CUSTOMER CARE REVIEWED THE INSTRUCTION FOR USE TO THE CUSTOMER. THE CUSTOMER REFUSED TO PROVIDE FACILITY CONTACT INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK