MAUDE Adverse Event Report: MEDIVATORS INC. MINNCARE HD; MINNCARE DISINFECTANT

Model Number	3029764
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was discovered that the bottles subject of the reported event were cracked and may have been dropped.Additionally, it was discovered that the bottles expired in august 2024 and that user facility personnel were wearing surgical masks while cleaning up the spill.The minncare hd disinfectant sds states, "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." the sds further states, "keep only in original container.Use only outdoors or in a well-ventilated area.Do not breathe dusts or mists.Store in a well-ventilated place.Keep container tightly closed.Store locked up.Dispose of contents/container in accordance with local/regional/national/international regulations." steris offered in-service training on the proper handling and storage of minncare hd disinfectant, however the user facility declined.A 2-year complaint review indicates this to be an isolated event.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.
Event or Problem Description
The user facility reported via chemtrec report that five employees experienced inhalation/irritation effects while cleaning up disinfectant that had leaked from two bottles of minncare hd disinfectant inside a closet.The employees did not seek medical treatment.

• Brand Name: MINNCARE HD
• Common Device Name: MINNCARE 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: 22923458
• Report Number: 2150060-2025-00027
• Device Sequence Number: 21102143
• Product Code: NIH
• UDI-Device Identifier: 00724995223298
• UDI-Public: (01)00724995223298
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K133724
• 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): 08/29/2025

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: 3029764
• Device Catalogue Number: 3029764
• 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: 07/30/2025
• Initial Report FDA Received Date: 08/29/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown