MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CIDEX¿ OPA TEST STRIPS; BIOCIDES TEST STRIPS

Catalog Number 20392

Device Problem Use of Device Problem (1670)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

A customer reported two events where expired cidex¿ opa test strips were used to verify the minimum effective concentration (mec) for the cidex¿ opa solution, and the affected scopes were released and used on patients.There was no report of infection, injury or harm to the patients associated with this issue.Although no prior incidents have resulted in serious injury, asp has decided to report all incidents where high-level disinfection cannot be assured and the device was released and used on a patient without reprocessing.This medwatch report is being submitted for the first event at the customer facility.Refer to manufacturer report number 2084725-2022-00211 for the second event related to this use error.

Manufacturer Narrative

Per the cidex¿ opa test strips instructions for use (ifu): ¿always note the date the bottle was opened and the ¿do not use after¿ date in the space provided on the bottle.¿ the batch record was reviewed, and no issues were observed that would contribute to the event.The involved lot met manufacturer specifications at the time of release.Asp will continue to follow up regarding this event.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

An asp representative visited the customer facility to review the cidex opa procedure and identified that a new employee had made the use error with expired cidex opa test strips.The customer was provided onsite retraining.Asp investigation summary: the investigation included a review of the batch record, trending analysis by lot number, and system risk analysis (sra).Trending analysis by lot number for the cidex opa test strips was reviewed for the prior six months from the 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." the expired cidex opa test strips were not returned for evaluation.In addition, use error has been identified for this event; therefore, no further evaluation or supplier investigation was conducted.The most likely assignable cause for this event can be attributed to user error in not following the cidex opa test strips instructions for use, which states to always note the date the bottle was opened and the ¿do not use after¿ date in the space provided on the bottle.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: CIDEX¿ OPA TEST STRIPS
• Type of Device: BIOCIDES TEST STRIPS
• 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: 15060114
• MDR Text Key: 304703479
• Report Number: 2084725-2022-00210
• Device Sequence Number: 1
• Product Code: JOJ
• UDI-Device Identifier: 30705037045550
• UDI-Public: 30705037045550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991709
• 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: 10/20/2022

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: 12/28/2021
• Device Catalogue Number: 20392
• Device Lot Number: 037541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1