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

Catalog Number 20690

Device Problem Use of Device Problem (1670)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

A customer initially reported that the cidex¿ opa bottle opening does not fit their non-asp reprocessor (td100 tee probe disinfector).On (b)(6) 2022, the customer provided additional information that their facility does not use cidex¿ opa test strips to verify the minimum effective concentration (mec) and does not monitor the solution temperature when they use the cidex¿ opa with the non-asp td100 reprocessor.The customer stated the reprocessing room is maintained at temperatures of 22c to 23c, and therefore, the cidex¿ opa solution is the same temperature as the room.There was no report of infection, injury or harm to patient(s) associated with this event.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, asp has determined in this situation high-level disinfection cannot be assured.Therefore, asp has decided to report all incidents where high-level disinfection cannot be assured and the device was released and used on patient(s).

Manufacturer Narrative

Initial reporter phone number: (b)(6).The batch record was reviewed, and no issues were observed that would contribute to this event.The product met manufacturer specifications at the time of release.An asp representative provided customer retraining as per the cidex¿ opa solution instructions for use (ifu): ¿cidex opa solution is a high level disinfectant for semi-critical devices when used or reused, according to the directions for use, at or above its minimum effective concentration (mec) of 0.3% as determined by cidex opa solution test strips, at 20°c (68°f) with an immersion time of at least 5 minutes for a reuse period of up to 14 days.¿ and it is recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met.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: the investigation included a review of the batch history record, trending analysis by lot number, and system risk analysis (sra).Trending analysis for the lot number was reviewed from manufactured date to event 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." use error has been identified to have contributed to the event, and therefore, no further product evaluation or supplier investigation was completed.The most likely assignable cause can be attributed to failure to follow the cidex® opa solution instructions for use (ifu).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: 15153567
• MDR Text Key: 297189915
• Report Number: 2084725-2022-00233
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K991487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Catalogue Number: 20690
• Device Lot Number: 240621/203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2021
• 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