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

Catalog Number	20391
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Asthma (1726); Nasal Obstruction (2466); Bronchospasm (2598); Cough (4457); Wheezing (4463); Unspecified Eye / Vision Problem (4471)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer initially reported two health care workers (hcws) who were in contact with cidex® opa solution for two months experienced a trigger of ¿bronchial asthma¿ on (b)(6) 2022, with symptoms of cough, bronchospasms, and rhinitis.The reported durations for the symptoms were 12 months for hcw1 and 6 months for hcw2; however, the duration for each specific symptom was unknown.The initially reported event details suggested a pre-existing illness/health condition since the onset of the symptoms predated the exposure to cidex® opa.On (b)(6) 2022, additional event information was provided that hcw1 is a 45-year-old female who had no history of asthma or known allergies prior to working in the hospital¿s endoscopy unit.Her injury outcome was noted as ¿unresolved,¿ and she ¿still has asthmatic crises, remains away from work¿; however, it was reported the condition has not caused permanent impairment, and she did not experience anaphylaxis.Hcw1 also experienced eye irritation that lasted for the 12-hour work shift, and it resolved when the she left.It was reported no medications were administered at the time of the event; however, the hcw had visited a physician prior to the event date of (b)(6) 2022, visit date not specified, and she was prescribed prednisolone, codeine, seretide and salbutamol for the coughing, wheezing, and bronchospasm that presented intermittently for two months, as well as for the nasal congestion that lasted for the 12-hour work shift.The customer reported additional details that the cidex® opa reprocessing room is small and not well ventilated; however, the room has an exhaust for air exchanges and an extractor hood installed above the cidex® opa solution.It was reported that a non-asp detergent, ¿indazyme max 7 enzymatic detergent¿ manufactured by indalabor, was used to preclean devices in the same room.The devices involved in this event were olympus endoscopes, and the scopes were manually reprocessed with cidex® opa solution in trays with tight-fitting lids for 10 minutes and were sufficiently rinsed post processing.The hcw wore personal protective equipment (ppe), including apron, hat, gloves, goggles, and an n95 mask with an activated carbon filter.Although the frequency of exposure to cidex® opa could not be determined with certainty, it was approximated to be from 1.5 hours to 6 hours every other day.Lastly, it was reported the hcw was not formally trained on proper use of cidex® opa.The new clinical details reported hcw1 experienced a respiratory reaction after working with cidex® opa for 2 months, and she did not have pre-existing allergies or asthma; therefore, this event has been deemed a serious injury due to the required treatment with medications, although considered standard of care.This medwatch report captures the event for hcw1, refer to manufacturer report number 2084725-2022-00232 for hcw2.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).Initial reporter zip code: (b)(6).Per the cidex® opa instructions for use (ifu): repeated contact may cause skin and respiratory sensitization.Avoid exposure to ortho-phthalaldehyde vapors, as they may be irritating to the respiratory tract and eyes.May aggravate a pre-existing asthma or bronchitis condition.Use cidex opa solution in a dedicated room with adequate ventilation and in closed containers with tight-fitting lids.Please reference local/state/country requirements for appropriate number of air exchanges per hour.If adequate ventilation is not provided by the existing air handling system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air.If using filtering face pieces, please ensure that they are capable of preventing inhalation of vapor.Do not use filtering face pieces that are only designed to prevent inhalation of particulates (e.G.Do not use n95 filtering face piece respirator).The batch history record was reviewed, and no issues were observed that would contribute to the reported event.The reported lot number met manufacturer specifications at the time of product release.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Additional information reported that the hcw's facility became aware of the her symptoms on 20-may-2022, and the hcw underwent spirometry testing (unspecified date) for diagnosis of asthma symptoms.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Correction: asp became aware that retains testing information was missing in the follow-up report #1, and blocks d9 and h6-type of investigation have been updated accordingly.The hcw¿s facility also provided clarification that from january to march 2022, the hcw covered lunch shifts for other employees and manually reprocessed scopes using cidex® opa, lot numbers unknown.Approximately on april 23rd to may 15-20th of 2022, the hcw worked 12 hour shifts every other day and reprocessed scopes manually.During this time frame, it was estimated she was exposed to cidex® opa for 1 hour 40 minutes to 6 hours per shift (3 days per week).The facility reported that the hcw¿s last day of employment was 20-may-2022, and on that day, she notified the facility occupational doctor and the endoscopy department that she had an asthma attack, and presented medical documents and claimed she was diagnosed with ¿bronchial asthma¿ by a private doctor.The medical records indicated that the hcw had no previous history of asthma and ¿episodes started after the occupational exposure¿.The exact date the hcw saw the private doctor is unknown, but the best estimate is between may 15th to may 20th of 2022, when the hcw stopped working with cidex® opa.The occupational doctor reported that the hcw showed partial response to treatment and maintained use of corticosteroids and bronchodilator - seretide and salbutamol; however, it is not known if the hcw currently continues to take these medications.The occupational doctor reported diagnosis made by the private doctor was considered ¿acute¿, and spirometry test was done to diagnose asthma; however, the test results are not available.As per asp clinical team's assessment of the information received, block h6-health effect - clinical code was updated to include asthma (1726); however, it was noted the condition has not caused permanent impairment.An asp representative retrained the facility/hospital department as per the cidex® opa instructions for use (ifu), including use of the product in a well-ventilated room and use of filtering face pieces capable of preventing inhalation of vapor.H3: asp investigation summary: the investigation included a review of the batch record, trending analysis by lot number, system risk analysis (sra), and retains testing.¿ retains testing was completed with no issues identified.All results obtained are within limits; the retained sample meets finished product specification requirements.¿ trending analysis for the lot number was reviewed for the prior six months from the event date, and no significant trend was observed.¿ review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the involved cidex® opa solution was not available for product evaluation, and the supplier investigation concluded with: ¿it is not possible to determine the exact root cause for this issue.Following review of the batch documentation and qc testing of the retained sample it was confirmed that this lot met finished product specification requirements.It is not possible to confirm this complaint.¿ the most likely assignable cause for the adverse event may be attributed to use error in not following cidex® opa ifu regarding use in a well-ventilated area and wearing appropriate personal protective equipment (ppe) capable of preventing inhalation of vapor.Per the cidex opa ifu, ¿avoid exposure to ortho-phthalaldehyde vapors, as they may be irritating to the respiratory tract and eyes.May cause stinging sensation in the nose and throat, discharge, coughing, chest discomfort and tightness, difficulty with breathing, wheezing, tightening of throat, urticaria (hives), and/or sensitization/anaphylaxis in rare instances, rash, loss of smell, tingling of mouth or lips, dry mouth or headache.May aggravate a pre-existing asthma or bronchitis condition.¿ 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: 15033325
• Report Number: 2084725-2022-00212
• Device Sequence Number: 19573287
• Product Code: MED
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 20391
• Device Lot Number: 060721/223
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 07/29/2022; 08/30/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/26/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female