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

Catalog Number	20392
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an expired cidex¿ opa test strip was used to verify the minimum effective concentration (mec) for the cidex¿ opa solution.No performance issues were reported; the customer stated, ¿the result was as expected,¿ and the affected load was released for patient use.There was no report of infection, injury or harm to patients associated with this event.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 has been retrained that the product should not be used after the expiration date.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.¿ additional event information was requested; however, the customer did not provide further details.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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).
Additional Manufacturer Narrative
Asp investigation summary: ¿ trending analysis could not be conducted due to unknown lot number.¿ the expired cidex opa test strips were not returned for evaluation.¿ review of risk documentation shows the risk for exposure to to biohazardous, pathogenic, or infectious material to be "low." 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: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 17905623
• Report Number: 2084725-2023-00292
• Device Sequence Number: 8225053
• Product Code: JOJ
• UDI-Device Identifier: 30705037045550
• UDI-Public: 30705037045550
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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 Catalogue Number: 20392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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