BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 2179426 · Received July 27, 2011

    Report

    Report Number
    2084725-2011-00055
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2010
    Report Date
    July 7, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, BATCH RECORD REVIEW, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE AND MISUSE AND HEALTH HAZARD EVALUATION. COMPLAINT HISTORY TRENDING WAS PERFORMED FOR THE PROBLEM CODE HRU-ANAPHYLACTIC REACTION. IT DID NOT REVEAL A SIGNIFICANT TREND. A BATCH RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. (B)(4). THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION. THERE WAS NO RESPONSE TO THE FOLLOW-UP ATTEMPTS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ASSIGNABLE CAUSE OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE CIDEX OPA ORTHO-PHTHALALDEHYDE SOLUTION INSTRUCTIONS FOR USE STATES IN PART: CONTRAINDICATIONS: CIDEX OPA SOLUTION SHOULD NOT BE UTILIZED TO PROCESS ANY UROLOGICAL INSTRUMENTATION USED TO TREAT PATIENTS WITH A HISTORY OF BLADDER CANCER. IN RARE INSTANCES CIDEX OPA SOLUTION HAS BEEN ASSOCIATED WITH ANAPHYLAXIS-LIKE REACTIONS IN BLADDER CANCER PATIENTS UNDERGOING REPEATED CYSTOSCOPIES. CIDEX OPA SOLUTION SHOULD NOT BE UTILIZED TO PROCESS INSTRUMENTATION FOR PATIENTS WITH KNOWN SENSITIVITY TO CIDEX OPA SOLUTION OR ANY OF ITS COMPONENTS. CIDEX OPA SOLUTION SHOULD NOT BE USED TO STERILIZE HEAT SENSITIVE MEDICAL DEVICES. WHEN STERILIZATION BY A BIOLOGICALLY MONITORABLE PROCESS IS NOT FEASIBLE, HIGH LEVEL DISINFECTION OF RIGID ENDOSCOPES IS RECOMMENDED BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AND THE ASSOCIATION FOR PROFESSIONALS IN INFECTION CONTROL AND EPIDEMIOLOGY (APIC).

    Description of Event or Problem · 1

    A CUSTOMER ALLEGED THAT WITHIN THE LAST TWELVE MONTHS ((B)(6) 2010 TO (B)(6) 2011) THERE HAVE BEEN AN ESTIMATED 20-24 ANAPHYLACTIC REACTIONS REPORTED ON PATIENTS THAT HAVE BLADDER CANCER AND HAVE UNDERGONE CYSTOSCOPY. THE FACILITY USES CIDEX OPA TO PROCESS SOME RIGID SCOPES AND FLEXIBLE SCOPES. THEY WASH THE INTERNAL CHANNEL USING A SYRINGE AND THEN RINSE WITH CLEAN WATER. THEY RINSE THREE TIMES CHANGING THE RINSE WATER BETWEEN EACH USE. THE REPORTER STATED THE FACILITY DID NOT HAVE THE IFU (INSTRUCTIONS FOR USE) FOR THE SOLUTION. SHE WAS ADVISED THAT THE CONTRAINDICATION FOR UROLOGY/BLADDER CANCER PATIENTS IS ON THE BOTTLE LABEL. ADDITIONALLY, THE FACILITY USES SKLAR (3 SPOONFULS WITH 1/2 GALLON OF WATER). A COPY OF THE CIDEX OPA IFU WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER REPORTED 20-24 EVENTS ANECDOTALLY AT THIS TIME. THE CUSTOMER WAS ASKED TO PROVIDE EVENT AND PATIENT INFORMATION. ASP WILL REPORT ADDITIONAL INFORMATION RECEIVED IN A SUPPLEMENTAL MEDWATCH REPORT(S).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1