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

Catalog Number	20398
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	10/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an event of expired cidex opa concentrate being used to reprocess instruments, which were released for use on patients.The expired disinfectant was in use for approximately four weeks before the error was discovered, and the affected instruments were released and used on 13 patients.There was no report of any injuries or human reactions.As a matter of policy, advanced sterilization products (asp) has decided to report all cases where a customer uses expired product and releases it for use on patients since high level disinfection cannot be assured.The expired cidex opa concentrate was used in two evotech¿ ecrs at this facility.This report is for evotech #2 and patient #2, refer to the manufacturer report number 2084725-2021-00434 for the report on evotech #1 and patient #1.
Additional Manufacturer Narrative
Thirteen patients were reported to have procedures performed with the affected instruments processed with expired cidex opa concentrate by two evotech¿ ecrs at the facility; however, it is unclear which evotech¿ ecr was involved for each patient.Advanced sterilization products will continue to follow-up for additional information regarding this event.The facility was advised that as per the cidex opa concentrate instructions for use (ifu), the input of the lot number and the expiration date must be manually entered into the evotech¿ ecr.The customer reported that the facility unit had been re-trained.The batch record review was performed and no issues relating to the failure mode were noted.The involved batch met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Correction - incorrect information reported in block b5 for the initial report: this medwatch report is not for ¿patient #2¿ ¿ this report is being submitted for unknown number of patients.Multiple attempts were made to obtain additional event information; however, the customer could not provide additional details for the reported issue.There are still no injuries or human reactions reported for this event, and the exact number out of the thirteen patients involved with the affected instruments/loads for evotech #2 is still unknown.If additional information becomes available, a supplemental report will be submitted as applicable.Asp investigation summary: the investigation included a review of the batch history record, trending analysis of the lot number, and system risk analysis (sra).¿trending analysis of the lot number was reviewed for the prior six months from open date and no significant trend was observed.¿review of risk documentation shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." product return and supplier investigation are not required as the reported issue is use error and not a deficiency against the product.The most likely assignable cause of this issue was failure to follow the cidex® opa concentrate ifu, which requires the lot number and expiration date to be verified and manually entered into the evotech ecr prior to use.Asp will continue to track and trend this issue.Asp complaint ref #: cmp-(b)(4).

• Brand Name: CIDEX OPA CONCENTRATE
• 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: 12861933
• Report Number: 2084725-2021-00435
• Device Sequence Number: 11841620
• Product Code: MED
• UDI-Device Identifier: 20705037000132
• UDI-Public: 20705037000132
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K032959
• 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,Followup
• Report Date (Section B): 12/21/2021

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 Expiration Date: 09/16/2021
• Device Catalogue Number: 20398
• Device Lot Number: 017500\072
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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