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	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported the employee was wearing proper ppe, specifically gloves.The following language related to safe handling of the rapicide pa high-level disinfectant can be found on the safety data sheets, "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 sheets include 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." it is likely that the package was stored in a non-upright position during transit allowing the rapicide pa high-level disinfectant to leak.The outer package labeling indicates that the package be stored in an upright position during transit.There have been no other complaints associated with this lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee was moving a package that leaked containing rapicide pa high level disinfectant and obtained a burn on their forearm.The employee rinsed the affected area and medical treatment was sought and administered (ointment) at the facility's er.

• 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: 18859842
• Report Number: 2150060-2024-00016
• Device Sequence Number: 3307007
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/07/2024

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: ML02-0117
• Device Lot Number: 607430
• 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: 02/08/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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