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

Catalog Number	20392
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The batch record was reviewed and no issues relating to the event were noted.The involved product met manufacturer specifications at the time of release.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.¿ 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).
Event or Problem Description
A customer reported an event where expired cidex¿ opa test strips were used to verify the minimum effective concentration (mec) for the cidex¿ opa solution, and two affected probes 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.
Additional Manufacturer Narrative
The customer provided additional information that the use of expired cidex¿ opa test strip was due to the technician not paying attention.The customer confirmed it was user error and that no issues with the label and no damage to the cidex¿ opa test strips bottle were observed.An asp representative visited the customer facility to review the cidex¿ opa procedure and 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 have been discarded and not available for evaluation.In addition, use error has been identified for this event; therefore, no further product evaluation or supplier investigation was completed.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
• Common Device Name: 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: 15303517
• Report Number: 2084725-2022-00250
• Device Sequence Number: 5340088
• Product Code: JOJ
• UDI-Device Identifier: 30705037045550
• UDI-Public: 30705037045550
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K991709
• 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): 09/27/2022

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: 06/28/2022
• Device Catalogue Number: 20392
• Device Lot Number: 3231132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown