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

Catalog Number 20390

Device Problems Inadequate or Insufficient Training (1643); Device Disinfection Or Sterilization Issue (2909)

Patient Problem Skin Discoloration (2074)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

Corrected catalog #: 20390-93, corrected lot # 617500099.The facility reported there is one dedicated staff member who cleans and reprocesses the masks, but others who also know the process.However, they did state that not all staff are properly trained on using cidex® opa solution.Their cleaning methods include submerging the masks in cidex® opa solution and referred to this as a ¿cold sterile¿ solution.They stated they do not measure the temperature prior to use.Per the cidex® opa solution ifu, the solution must be at a minimum 68 degrees f for high level disinfection.Regarding their rinsing process, they stated they rinse the masks under running water for ¿about 2-3 minutes.¿ the ifu states to thoroughly rinse by immersing completely in a large container of water for a minimum of one-minute duration.This process is to be repeated 2 additional times.There are no serious injuries reported with this event; however, since the customer used cidex® opa solution at a potentially lower temperature than recommended in the ifu, asp has determined high level disinfection cannot be assured, and as a matter of policy, asp has decided to report cases where a customer uses cidex® opa below the required minimum temperature.This event will be reassessed if new information becomes available.(b)(4) are related complaints from the same facility.Please reference mdr¿s # 2084725-2017-00063, 2084725-2017-00064, 2084725-2017-00065 and 2084725-2017-00066.

Event Description

A facility reported four patients had skin staining on their cheekbones and nose, after a ¿laughing gas mask¿ was used during a dental procedure which had been processed in cidex® opa solution.This report is for patient #3, an (b)(6) -year old female patient who had a dental procedure with oral sedation and nitrous oxide on (b)(6) 2017 from 10:24 am to 11:03 am.Her symptoms were ¿dark staining on cheekbones and nose" and were noticed ¿as soon as nitrous mask was removed¿.It was unknown exactly how long her symptoms lasted, but it was confirmed later the staining had completely resolved, and the dental office manager reported she was ¿fine¿.She did not receive any medical attention.After further follow-up, the facility stated they had recently started using cidex ® opa solution to process multiple-patient use, nitrous oxide nasal masks manufactured by ¿porter¿.Four patients developed ¿staining¿ immediately after these masks were used; however, there were other patients which used masks processed in cidex® opa solution which had no staining.Since the events happened, it was confirmed the facility is no longer using cidex® opa solution to reprocess masks.Instead, they have resumed their process using a non-asp product, which they reported they have never had any issues with.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the batch history record, complaint trending, visual analysis, visual analysis and retains analysis.The batch history record could not be reviewed as the lot number was not available.Complaint trending by lot number was reviewed from 07/17/2016 to 01/13/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." visual analysis was not performed since the product was not returned.The supplier was not notified of the issue as the issue was not identified as a manufacturing or functional issue.Retains testing was not performed as the issue was not identified as a manufacturing or functional issue.The likely assignable cause of this issue was due to improper rinsing and not measuring the temperature of the solution prior to use.The customer was informed how to properly heat cidex® opa solution and proper rinsing techniques per the instructions for use (ifu).The issue will continue to be tracked and trended.

• Brand Name: CIDEX OPA SOLUTION
• Type of Device: BIOCIDES SOLUTIONS (MED)
• 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: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6311244
• MDR Text Key: 67226336
• Report Number: 2084725-2017-00065
• Device Sequence Number: 1
• Product Code: MED
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: 20390
• Other Device ID Number: 20390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 8 YR