MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

Model Number	1C3308
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Headache (1880)
Date of Event	04/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that employees experienced inhalation/irritation after handling the prolystica 2x concentrate enzymatic presoak and cleaner.No medical treatment sought or administered.
Additional Manufacturer Narrative
The employees subject of the event are located at four different scott & white health locations.It is unknown if the employees were wearing proper ppe at the time of the reported event.A steris clinical specialist arrived onsite at one of the customer's locations to review the proper use and handling practices for the cleaner.The clinical specialist observed the user facility personnel wear the proper ppe and no adverse effects or symptoms were experienced by the personnel.One of the four locations was confirmed to not have proper ventilation in the room where the product is handled.It is unknown if the other three locations have proper ventilation.The prolystica 2x concentrate enzymatic presoak and cleaner safety data sheet states, "precautions for safe handling: provide good ventilation in process area to prevent formation of vapor." additionally, nsi/aami st58 states, "chemical sterilants/high-level disinfectants should be used in an area that is properly ventilated.Rooms in which chemical disinfection and sterilization are performed should be large enough to ensure adequate dilution of vapor and should have a minimum air exchange rate of 10 air exchanges per hour (local regulations might require a higher minimum exchange rate)." a steris clinical specialist counseled facility personnel on the proper use of prolystica 2x concentrate enzymatic presoak and cleaner, specifically proper ventilation.The user facility has discontinued the use of prolystica 2x concentrate enzymatic presoak and cleaner.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER
• Common Device Name: CLEANER
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15008621
• Report Number: 1937531-2022-00001
• Device Sequence Number: 6753129
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: 00724995087517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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 Model Number: 1C3308
• Device Catalogue Number: 1C3308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown