MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CIDEX OPA SOLUTION; BIOCIDES SOLUTIONS (MED)

Catalog Number	20390
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported using cidex® opa solution past the 14-day reuse date and the instruments were released and used on patients.The customer stated the solution was tested prior to use and met the minimum effective concentration (mec).There were no reports of any injury, harm or infections reported.Per the instructions for use (ifu), cidex® opa solution may be reused for up to a maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the directions for use.Do not rely solely on days in use.Concentration of this product during its reuse life must be verified by the cidex® opa solution test strip prior to each use to determine that the concentration of ortho-phthalaldehyde is above the mec of 0.3%.The product must be discarded after 14 days, even if the cidex® opa solution test strip indicates a concentration above the mec.Although there is no patient harm or injury reported, advanced sterilization products has decided to report cases when the customer uses expired product and releases the instruments for use since high-level disinfection cannot be assured.
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the batch history record, complaint trending of lot number, system risk analysis (sra), visual analysis, and supplier evaluation.¿ the batch history record could not be reviewed as the lot number was not available.¿ complaint trending by lot number could not be performed as the lot number was not available.¿ the sra shows the risk for ¿exposure to biohazardous, pathogenic or infections material¿ is low.¿ visual analysis was not performed as the product was discarded by the customer.¿ the supplier was not notified since the issue was not identified as a manufacturing or functional issue.The likely assignable cause of this issue was due to an unintended user error.The customer reviewed the instructions for use (ifu) with the asp clinical education consultant and initiated action with their risk management and infection control at the facility.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CIDEX OPA SOLUTION
• Common Device Name: BIOCIDES SOLUTIONS (MED)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 9812390
• Report Number: 2084725-2020-50028
• Device Sequence Number: 2788846
• Product Code: MED
• UDI-Device Identifier: 20705037000071
• UDI-Public: 20705037000071
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K991487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 20390
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1