BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 6156822 · Received December 8, 2016

    Report

    Report Number
    2084725-2016-00757
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    January 30, 2012
    Report Date
    November 15, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K924434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED STERILIZATION PRODUCTS (ASP) HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS 2002 PUBLICATION AND EVENT, INCLUDING CIDEX® PART AND LOT NUMBERS, BUT HAS RECEIVED NOTHING FURTHER TO DATE. FURTHERMORE, ASP IS UNABLE TO CONFIRM IF THIS EVENT WAS CAPTURED IN A PREVIOUS COMPLAINT. BASED ON THIS LIMITED INFORMATION, A DECISION WAS MADE TO FILE A FDA MEDWATCH REPORT. THE DETAILS OF THE INJURY ARE UNKNOWN; HOWEVER, ASP HAS DECIDED TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION, AND DUE TO THE FACT THAT CIDEX WAS MENTIONED. FURTHER INVESTIGATION IS BEING DONE, AND THIS COMPLAINT WILL BE RE-ASSESSED IF NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD, COMPLAINT TRENDING, 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 ISSUE WAS NOT ISOLATED TO A SPECIFIC LOT OR LOTS. THE SRA INDICATES THE RISK ASSOCIATED WITH EXPOSURE TOXIC OR CORROSIVE MATERIAL IS "LOW." VISUAL ANALYSIS WAS NOT PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THE SUPPLIER WAS NOT NOTIFIED OF THE ISSUE WAS NOT IDENTIFIED AS A MANUFACTURING OR FUNCTIONAL ISSUE. RETAINS TESTING WAS NOT PERFORMED AS THE ISSUE WAS NOT ISOLATED TO A SPECIFIC LOT OR LOTS. THE ASSIGNABLE CAUSE OF THIS ISSUE COULD NOT BE VERIFIED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED BASED ON A LITERATURE REVIEW OF PUBMED ID 27740306. THE TITLE IS ¿UNIONS WELCOME CIDEX® WITHDRAWAL,¿ AND WAS PUBLISHED IN PRINT IN THE ¿NEWS¿ SECTION OF NURSING STANDARD FROM THE UNITED KINGDOM IN JANUARY 2002. THE WEBSITE LINK IS AS FOLLOWS: HTTP://DX.DOI.ORG/10.7748/NS.16.20.8.S20. IN THIS NEWS ARTICLE, IT WAS REPORTED ¿HEALTHCARE UNIONS HAVE WELCOMED THE WITHDRAWAL FROM THE MARKET OF THE GLUTARALDEHYDE DISINFECTANT, CIDEX®¿. IT WAS ALSO REPORTED CIDEX® WAS TO BE TAKEN OFF THE MARKET ON MAY 1ST, 2002, AND WOULD BE REPLACED WITH CIDEX® OPA. LASTLY, IT REPORTED STAFF DEVELOPED ASTHMA AND SKIN PROBLEMS LINKED TO CIDEX®; AND ONE HEALTH CARE WORKER (HCW) DEVELOPED ¿ASTHMA THAT WAS LINKED TO HER USE OF THE PRODUCT TO STERILISE INSTRUMENTS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805849 CIDEX ACTIVATED DIALDEHYDE SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1