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

Catalog Number 20390

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported they are not testing their cidex® opa solution for the minimum effective concentration (mec) prior to use and the affected loads are being released for use to patients.There are no known injuries or infections reported as a result of the issue.The cidex® opa solution instructions for use (ifu) states that cidex® opa test strips should be used prior to each use to test for the mec.It states, ¿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.¿ asp has determined that in this situation, high level disinfection cannot be assured.Therefore, asp has decided to report all incidents as a matter of policy if the loads have been released without reprocessing.The customer was advised to always test the cidex® opa solution prior to each use.A copy of the instructions for use (ifu) for both the cidex® opa solution and the cidex® opa solution test strip was sent to the customer.

Manufacturer Narrative

The investigation included a review of the batch history record, complaint trending and system risk analysis (sra).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 indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the likely assignable cause of this issue was failure to follow instructions.A copy of the instructions for use (ifu) for both the cidex opa solution and the cidex opa solution test strip was sent to the customer.The issue will continue to be tracked and trended.(b)(4).

• Brand Name: US CIDEX® OPA SOLUTION
• Type of Device: BIOCIDES SOLUTIONS
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7558700
• MDR Text Key: 109769725
• Report Number: 2084725-2018-00608
• Device Sequence Number: 1
• Product Code: MED
• UDI-Device Identifier: 10705037000074
• UDI-Public: 10705037000074
• Combination Product (y/n): N
• PMA/PMN Number: K991487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

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 Catalogue Number: 20390
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1