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 Code	Burn(s) (1757)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee received a burn on their hands while removing a bottle of rapicide pa high level disinfectant part a from a damaged box.The employee washed their hands with water and continued working; symptoms fully resolved the next day.
Additional Manufacturer Narrative
The user facility reported that bottles of rapicide pa high-level disinfectant became damaged in transit.The user facility was unable to confirm the subject lot of the bottle involved in the reported event.No ppe was worn by the user, specifically gloves, during the unpacking process.Steris offered in-service training on the proper use of ppe; however, the user facility declined.The following language related to safe handling of the rapicide pa high-level disinfectant can be found on the safety data sheet, "in case of contact, immediately flush skin with plenty of water.Remove contaminated clothing and shoes.Wash clothing before reuse.Get immediate medical advice/attention.Causes severe skin burns.Symptoms may include redness, pain, blisters." the safety data sheet includes the following language related to ppe, "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." fedex retrieved the damaged box from the user facility.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.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: RAPICIDE PA HIGH-LEVEL 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
• MDR Report Key: 20796174
• Report Number: 2150060-2024-00057
• Device Sequence Number: 7894441
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 11/27/2024

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: 10/29/2024
• Initial Report FDA Received Date: 11/27/2024
• 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