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

Catalog Number 20390

Device Problem Use of Device Problem (1670)

Patient Problem Skin Discoloration (2074)

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

The customer was retrained on proper reprocessing with cidex® opa solution as per the instructions for use.Per the cidex® opa ifu, under manual processing: ¿high level disinfectant at a minimum of 20°c (68°f).Cidex opa solution is a high level disinfectant when used or reused, according to the directions for use, at or above its minimum effective concentration (mec) as determined by cidex opa solution test strips, with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.¿ and ¿three (3) separate, large volume water immersion rinses are required.¿ the rinsing procedure stated the device must be thoroughly rinsed by immersing completely in a large volume of water (e.G.2 gallons) for a minimum of one minute, and to repeat for a total of three rinses with large volumes of fresh water to remove cidex® opa solution residue.It was also recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met.Asp investigation summary: batch history record was not reviewed since the product lot number is not available.Trending analysis was not performed since the product lot number is not available.Review of risk documentation shows the risk for exposure to toxic or corrosive material and exposure to biohazardous, pathogenic, or infectious material to be "low." product evaluation was not conducted since the product was not returned and the product lot number was not available.Furthermore, product testing and supplier investigation are not required since the reported issues were determined to be use errors and not a deficiency against the product.The most likely assignable cause for the reported issues can be attributed to failure to follow the cidex® opa solution ifu, which recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met, and stated ¿three separate, large volume water immersion rinses are required.¿ asp will continue to track and trend this issue.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).

Event Description

A customer reported an event of medical instrument corrosion, and that a healthcare worker (hcw) experienced blue skin discoloration on the hands when processing with cidex® opa solution.The blue skin discoloration lasted for one day and resolved with several hand washings, and the customer reported that ¿no adverse skin reactions¿ occurred, only ¿temporary staining¿.In addition, 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.The hcw provided additional event information that stated the medical instruments/tools were first observed to be ¿damaged¿ on (b)(6) 2022.The hcw reported that the medical instruments were immersed in cidex® opa solution for two to five minutes, then the instruments were placed on paper to air dry.The hcw also reported that no test strips were used to measure the minimum effective concentration (mec), and the solution temperature was not monitored.Based on the additional information provided by the customer, multiple use errors have been identified per the cidex® opa solution instructions for use (ifu).The reported skin reaction has been determined to be minor as it resolved without medical intervention; however, this event is being reported as a malfunction report subsequent to a previous serious injury due to human contact with a medical device that was not rinsed per the cidex® opa ifu.Additionally, it was reported that cidex® opa solution was not tested for the mec, the temperature was not monitored, and the immersion time specification was not met.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).

• 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: 14686374
• MDR Text Key: 301600104
• Report Number: 2084725-2022-00168
• 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
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• 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: 05/23/2022
• 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