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

Catalog Number	20390
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: the correct brand name is cidex opa solution ghs.Catalog number: the correct catalog number is 20390_93, lot # 526500021, exp 9/21/2017.
Event or Problem Description
A customer reported they were inadequately rinsing their instruments after cleaning and disinfecting in cidexpa solution, and the instruments were released and used on patients.No serious injuries were reported.The customer stated they were unaware of the proper rinsing procedures and were soaking their endovaginal probes in a open container with no lid, then wrapping the probe in a wash cloth and rinsing the probe in the sink.The instructions for use (ifu) states the instruments should be submerged completely into a clean, large water container for a minimum of one minute.This should be repeated twice for a total of three rinses.Failure to rinse devices per the ifu may result in patient side effects, including serious allergic reaction to residues or discoloration of tissues.The customer was advised to follow the ifu from now on.As a matter of policy, advanced sterilization products (asp) has decided to report cases of improperly rinsed instruments after using cidex opa solution since it could result in serious patient side effects.
Additional Manufacturer Narrative
(b)(4).Lot #: 526500021.Asp investigation summary: the investigation included a review of the visual analysis, batch record, supplier evaluation, retains testing, batch trending, trending by lot #, and system risk analysis.A visual analysis was not performed as the issue was not identified to be a manufacturing or functional issue.The batch record was reviewed and did not identify any anomalies.Supplier evaluation was not required as this was not a manufacturing or functional issue.Retain testing was not performed as this was not a manufacturing or functional issue.Complaint trending by lot # was reviewed and did not identify a trend.The system risk analysis (sra) was reviewed for the issue of procedure related and the risk was determined to be "low risk." the assignable cause is failure to follow instructions.The customer was not properly rinsing their instruments according to the instructions for use (ifu).A customer letter will be sent providing further information on proper rinsing and instructions for use.Asp will continue to track and trend this issue.No further investigation is required at this time.

• Brand Name: CIDEX OPA SOLUTION
• Common Device Name: BIOCIDES SOLUTIONS (MED)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 5397724
• Report Number: 2084725-2016-00053
• Device Sequence Number: 198983
• Product Code: MED
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2016

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: 09/21/2017
• Device Catalogue Number: 20390
• Other Device ID Number: 20390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2016
• Supplement Report FDA Received Date: 02/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1