MAUDE Adverse Event Report: MEDIVATORS INC. RAPICIDE PA HIGH-LEVEL DISINFECTANT

Model Number	ML02-0117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Sore Throat (2396); Loss of consciousness (2418); Voice alteration (4906)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via chemtrec that there were two complaints of "sore throats" and "raspy voice" following rapicide pa high-level disinfectant bottles that leaked.No medical treatment was sought or administered and the employees continued working.
Additional Manufacturer Narrative
The chemtrec report did not provide a lot number for the rapicide pa high-level disinfectant subject to the reported event.The reported issue is likely attributed to damage during transit.The user reported to not be wearing proper ppe at the time of the event.Per the rapicide pa high-level disinfectant safety data sheet, "section 8.3: respiratory protection: in case of insufficient ventilation, wear suitable respiratory equipment.Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator.Other information: handle in accordance with good industrial hygiene and safety procedures." the rapicide pa high-level disinfectant bottles subject to the reported event were disposed of and not returned for evaluation.No additional issues have been reported.Udi related data clarification: the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Additional Manufacturer Narrative
Through follow-up with user facility personnel steris learned that the rapicide pa high-level disinfectant was damaged upon delivery by fedex and had been placed in a bag.The employees opened the bag which caused the reported event.Additionally, it was reported that the fedex driver fainted while unloading the damaged package and went to the emergency room for treatment.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23544886
• Report Number: 2150060-2025-00037
• Device Sequence Number: 9458139
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619(11)250826(17)270224(10)669617
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: ML02-0117
• Device Catalogue Number: ML020117
• Device Lot Number: (10)669617
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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