MAUDE Adverse Event Report: Medivators Inc Rapicide PA High-Level Disinfectant

Model Number	ML020117
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported while an employee was utilizing a rapicide pa test strip test after a cycle, the collection container was dropped subsequently causing rapicide pa high-level disinfectant to splash into the employee¿s eye.The employee flushed their eyes with water and sought treatment at the facility¿s emergency department.
Additional Manufacturer Narrative
During follow-up with user facility personnel, it was confirmed that the employee was wearing a gown and gloves during the time of the reported event.However, the employee had removed their eye shield once the scope was in the capital equipment.The instructions for use states, ¿wear protective gloves/protective clothing/eye protection/face protection.¿ steris offered in-service training on the proper use and handling for the rapicide pa high-level disinfectant and the user facility accepted.No additional issues have been reported.A follow-up report will be submitted upon completion of the in-service training.Udi related data clarification ¿ the lot number is unknown, therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: Rapicide PA High-Level Disinfectant
• Common Device Name: Rapicide PA High-Level Disinfectant
• Manufacturer (Section D): Medivators Inc; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer (Section G): Medivators Inc; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50238207
• Report Number: 2150060-2026-00036
• Device Sequence Number: 18730314
• Product Code: FEB
• UDI-Device Identifier: 00724995245962
• UDI-Public: (01)00724995245962
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• 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): 08/13/2026

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: ML020117
• Device Catalogue Number: ML020117
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/13/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown