MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CIDEX® OPA SOLUTION; BIOCIDES SOLUTIONS

Catalog Number	20390
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that his facility is not following the cidex® opa solution instructions for use (ifu) for minimum temperature and device rinsing, and he had contacted advanced sterilization products (asp) for confirmation of the correct process.He reported that as per the facility¿s instructions, cidex® opa solution was used to reprocess instruments when it was below minimum temperature of 68 degrees fahrenheit, and the facility also reused the rinse water.Asp confirmed and advised the customer that the minimum temperature for cidex® opa solution manual processing is 68 degrees fahrenheit, and the rinse water should be discarded after each rinse.The customer confirmed that the incorrectly processed instruments were released and used on patients.There was no report of any injuries or human reactions.As a matter of policy since high level disinfection cannot be assured, asp has decided to report all incidents of cidex® opa solution being used below the minimum temperature, with the affected instruments released and used on patients.It was also reported that there was human contact with a medical device that was not rinsed per cidex® opa solution ifu; therefore, this event is being reported as a malfunction subsequent to a previous serious injury for improper device rinsing.
Additional Manufacturer Narrative
The customer declined to provide the name or contact information for the facility where the event occurred.Additionally, the customer was advised on proper use of cidex® opa solution but declined a training for the facility.Multiple attempts were made to obtain additional information; however, the customer refused to provide further details regarding this event.Asp investigation summary: the batch record review could not be completed as the lot number was unknown.Retains testing was not completed as the lot number was unknown.Product evaluation was not completed as the suspect product was not available.Trending analysis could not be completed as the lot number was unknown.The sra indicates the risk for exposure to toxic or corrosive material is "low." the most likely assignable cause for the incorrect temperature for instruments reprocessing and improper device rinsing is failure to follow the cidex® opa solution ifu, which stated the minimum temperature should be 68 degrees fahrenheit for manual processing, and the rinse water should be discarded after each rinse.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: CIDEX® OPA SOLUTION
• Common Device Name: BIOCIDES SOLUTIONS
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 12865225
• Report Number: 2084725-2021-00417
• Device Sequence Number: 1361885
• Product Code: MED
• UDI-Device Identifier: 20705037000071
• UDI-Public: 20705037000071
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K991487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 20390
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown