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

Catalog Number 20390

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

A customer reported an event of multiple use errors identified at their facility involving instrument reprocessing with cidex® opa solution.The customer stated that approximately since (b)(6) 2022, the facility had been reprocessing with cidex® opa solution without monitoring the temperature or using the test strips to check the minimum effective concentration (mec), and the facility replaces the cidex® opa solution every 30 days instead of the maximum 14 days of reuse as per the cidex® opa instructions for use (ifu).Lastly, the customer reported instruments were released and used on patient(s).However; there was no report of infection, injury or harm to patients associated with this event.Although no prior incidents have resulted in serious injury related to these stated use errors, as a matter of policy, asp has decided to report all these incidents when the involved devices have been released for use on patient(s).

Manufacturer Narrative

The customer has declined product retraining stating that they have discontinued reprocessing with cidex® opa.Per the cidex® opa ifu: ¿reuse period for disinfection: cidex opa solution has demonstrated disinfection efficacy in the presence of 5% organic soil contamination and microbiological burden during reuse.Cidex opa solution may be reused for up to a maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the directions for use.Do not rely solely on days in use.Concentration of this product during its reuse life must be verified by the cidex opa solution test strip prior to each use to determine that the concentration of ortho-phthalaldehyde is above the mec of 0.3%.The product must be discarded after 14 days, even if the cidex opa solution test strip indicates a concentration above the mec.¿ this report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).

Manufacturer Narrative

Asp investigation summary: batch record review could not be performed due to unknown lot number.Trending analysis could not be conducted due to unknown lot number.Review of risk documentation shows the risk for exposure to biohazardous, pathogenic, or infectious material to be "low." the involved cidex® opa solution was not returned for product evaluation, and the supplier investigation could not be completed due to unknown lot number.The most likely assignable cause for this event can be attributed to use error in not following the cidex® opa instructions for use, which states the maximum reuse period for cidex® opa solution is 14 days at the required solution concentration and temperature, and the concentration must be verified by cidex® opa solution test strips prior to each use, and the solution temperature should be monitored during use.The customer reported they have discontinued use of cidex® opa.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: CIDEX® OPA SOLUTION
• Type of Device: 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: 14698979
• MDR Text Key: 301730770
• Report Number: 2084725-2022-00177
• Device Sequence Number: 1
• Product Code: MED
• UDI-Device Identifier: 20705037000071
• UDI-Public: 20705037000071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20390
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1