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

Model Number	ML02-0117
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A recycling plant reported via chemtrec report that a strong odor was detected coming from containers of rapicide pa high level disinfectant and several employees experienced inhalation/irritation.The employees moved to fresh air and their symptoms resolved.
Additional Manufacturer Narrative
Per follow-up discussion with a recycling plant employee, it was determined that the bottles had not been properly disposed of by the end user as some of the bottles were still full of product.It is unknown from which end user or customer the bottles were collected from by the recycling plant.The safety data sheet was provided to the recycling plant.The safety data sheets states, "first-aid measures after inhalation: if inhaled, remove to fresh air." the rapicide pa high level disinfectant instructions for use states, "after use, ensure that all containers are rinsed per epa rcra guidelines.Dispose of any unused material to include containers per local, state and federal regulations." no additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid information.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18336255
• Report Number: 2150060-2023-00053
• Device Sequence Number: 6712024
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619(11)230602(17)241120(10)586809
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 11/20/2024
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Device Lot Number: (10)586809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• 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