BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX SOLUTION (14 DAY) TEST STRIP, 15 STRIPS/BOTTLE

    MDR report key: 1386170 · Received March 11, 2009

    Report

    Report Number
    8021896-2009-00006
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 18, 2009
    Manufacturer
    ALBERT BROWNE LTD.
    Product Code
    JOJ
    PMA / PMN Number
    K922481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THEY HAVE BEEN USING EXPIRED CIDEX ACTIVATED SOLUTION TEST STRIPS FOR TWO MONTHS. THEY USE THE CIDEX TO DISINFECT LARYNGOSCOPE BLADES FOR ANESTHESIA DEPARTMENT. SHE DOES NOT KNOW HOW MANY LARYNGOSCOPE BLADES WERE USED ON PATIENTS. THE ASP CUSTOMER CARE REP INFORM CUSTOMER THAT ASP DOES NOT RECOMMEND THE USE OF ANY OF OUR PRODUCTS BEYOND THE EXPIRATION DATE. THE CUSTOMER REPORTED THAT THEY CHANGE THE CIDEX EVERY 2 WEEKS. SHE WAS INFORMED THAT EVEN THOUGH THEY DID THIS, THEY WOULD STILL NEED TO TEST WITH THE STRIP BEFORE EACH USE AS THIS IS THE ONLY WAY TO DETERMINE IF THE SOLUTION IS AT THE RIGHT MINIMUM EFFECTIVE CONCENTRATION (MEC) TO DISINFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX SOLUTION (14 DAY) TEST STRIP, 15 STRIPS/BOTTLE INDICATOR, CHEMICAL (JOJ) JOJ ALBERT BROWNE LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CIDEX ACTIVATED SOLUTION