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

Catalog Number	20390
Medical Device Problem Code	Failure to Disinfect (1175)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported using cidex® opa solution below the minimum temperature requirement of 68° fahrenheit for manual reprocessing of their instruments.The customer stated the solution was used at 65° fahrenheit and the reprocessed instruments were released and used on patients.The facility confirmed there were no patient symptoms and no serious injuries reported.Per the cidex® opa solution instructions for use (ifu), high level disinfection is achieved by the disinfectant when used at a minimum of 20° celsius (68° fahrenheit) with an immersion time of at least 12 minutes.As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer does not follow the ifu when processing their scopes in cidex® opa solution since asp is not able to guarantee it has been high level disinfected.
Additional Manufacturer Narrative
The customer declined to provide the facility name, details of the involved device, lot number, and expiration date.H3: asp investigation summary: the investigation included a review of the batch history record, complaint trending by lot number and system risk analysis (sra).The batch history record could not be reviewed as the lot number was not available.Complaint trending could not be performed as the lot number was not available.Review of risk documentation shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." the assignable cause of the issue was due to user error.The customer confirmed they were aware they needed to check for the acceptable temperature in the instructions for use to avoid a recurrence of this issue.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: US CIDEX OPA SOLUTION
• Common Device Name: BIOCIDES SOLUTIONS
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 12132091
• Report Number: 2084725-2021-00215
• Device Sequence Number: 4176430
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1