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

Model Number	ML02-0117
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The chemtrec report did not provide a lot number for the rapicide pa high-level disinfectant subject of the reported event.Steris made multiple attempts to contact the user facility to obtain additional information regarding the reported event however, the user facility has not responded.Without the user facility's response, steris is unable to determine a root cause.The safety data sheet for rapicide pa high-level disinfectant states (section 8), "use ventilation adequate to keep exposures (airborne levels of dust, fume, vapor, etc.) below recommended exposure limits.Ensure that eyewash stations and safety showers are close to the workstation location.Wear chemically resistant protective gloves.Wear approved eye protection (properly fitted dust- or splash-proof chemical safety goggles) and face protection (face shield).Wear suitable protective clothing.Wear solvent resistant apron and boots for spills." a follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported via chemtrec report that an employee "accidently" dropped rapicide pa high-level disinfectant (unknown if it was part a or part b) down the drain.The employee stated she got product on one of her arms which resulted in discoloration of the skin.The employee also stated a strong odor was present when the rapicide pa high-level disinfectant was dropped.The chemtrec report stated the employee was seeking medical attention on site.
Additional Manufacturer Narrative
Udi related data quality updates only - 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: 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: 18103784
• Report Number: 2150060-2023-00047
• Device Sequence Number: 20190699
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/09/2023

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 Model Number: ML02-0117
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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