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

Catalog Number	20390
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an event of two patients experienced adverse urinary reactions post cystoscopy procedures with instruments that were reprocessed with cidex opa solution.One of the two patients reported burning sensation right after the procedure; however, it is unclear which of the two patients experienced the immediate reaction.The customer stated that the incident is not considered a serious injury and reported that the patients are "fine".The patient received a local anesthetic (5% lidocaine jelly) injected into the urethra prior to the cystoscopy with a wolf flexible cystoscope.The patient experienced burning urethra while urinating post procedure.The patient was prescribed prophylactic oral antibiotics; however, it is not known if these antibiotics are given to all cystoscopy patients.Additionally, it was recommended to take azo, which is an oral over-the-counter (otc) medication, to relieve the burning sensation.It is not known if the patient took this otc medication or the duration of treatment.The customer provided that the instruments reprocessing procedure included immersion in a diluted non-asp detergent (prolystica), then immersion in cidex® opa solution, and then rinsed with sterile water for 60 seconds.The instruments are rinsed once again prior to use.As per the cidex® opa instructions for use (ifu), a minimum of three one-minute rinses are required.It was reported that the instruments are soaked in cidex opa solution for a maximum of 12 minutes, but sometimes 5 to 8 minutes; the actual cidex® opa immersion time for this event is unknown.It was reported that there was human contact with a medical device that was not rinsed per cidex® opa solution ifu; therefore, this event is being reported as a malfunction subsequent to a previous serious injury.This report is for patient 2.Refer to manufacturer report number 2084725-2021-00425 for patient 1.
Additional Manufacturer Narrative
The customer was provided the cidex® opa solution ifu and was retrained on proper cleaning with detergents, soak time, and rinsing procedure.The batch record review was performed and no issues relating to the failure mode were noted.The involved batch met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the batch history record, retains testing, trending analysis by lot number, and system risk analysis (sra).¿ retains testing was completed with no issues identified.All in-process controls are within specifications.¿ trending analysis for the lot number was reviewed for the prior six months from open date and no significant trend was observed.¿ review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." product evaluation was not performed as the issue was determined to be use error.Supplier investigation concluded that the root cause of the adverse event is considered unknown but to have occurred outside of the supplier control.Review of the manufacturing and packaging processes, testing results, and retain samples show no evidence of the supplier as the root cause.The most likely assignable cause of this issue was failure to follow the cidex® opa solution instructions for use (ifu) in proper cleaning with detergents, soak time, and rinsing procedure.Asp will continue to track and trend this issue.Asp complaint ref (b)(4).

• Brand Name: CIDEX® OPA SOLUTION
• Common Device Name: BIOCIDES SOLUTIONS
• 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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 12903017
• Report Number: 2084725-2021-00426
• Device Sequence Number: 4819764
• Product Code: MED
• UDI-Device Identifier: 20705037000071
• UDI-Public: 20705037000071
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K991487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 06/01/2023
• Device Catalogue Number: 20390
• Device Lot Number: 116000049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown