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

Catalog Number	20390
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was retrained on the correct rinsing procedure to include a total of three rinses as per the cidex opa solution ifu, and the customer provided that they have since switched to processing with medivator machines.The batch history record was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported that their facility did not follow the cidex® opa solution instructions for use (ifu) for instrument rinsing, and the instruments were released and used on patients.The facility confirmed there were no patient symptoms and no injuries reported.Per the cidex® opa solution instructions for use (ifu), a minimum of three one-minute rinses are required using large volumes of fresh water.It was 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.
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the device batch record, retains testing of lot, trending analysis by lot number, and system risk analysis (sra).Retains testing was completed with no issues identified.All in-process controls are within specifications.Trending analysis by lot number was reviewed for the six months prior to open date and trending was not exceeded.Review of risk documentation shows the risk for residual exposure to be "low." the product was not available for further evaluation.The issue has been attributed to user error as the healthcare worker (hcw) was not following the rinsing procedure in the cidex opa solution instructions for use.The issue will continue to be tracked and trended.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: 12936937
• Report Number: 2084725-2021-00427
• Device Sequence Number: 4884642
• Product Code: MED
• UDI-Device Identifier: 20705037000071
• UDI-Public: 20705037000071
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 01/06/2022

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: 06/10/2023
• Device Catalogue Number: 20390
• Device Lot Number: 116200052
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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