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

Model Number ML02-0117

Device Problem Insufficient Information (3190)

Patient Problem Chemical Exposure (2570)

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

Steris was made aware of an alleged injury on (b)(6) 2023.Steris has contacted the user facility requesting additional information regarding the reported event.However, the user facility declined to provide additional information.The user facility has three dsd edge aer units.Steris performed service on all three units after the event is alleged to have occurred on (b)(6) 2020.However, none of the service requests from the customer were related to a rapicide pa high-level disinfectant leak and no injury was reported.The serial number of the dsd edge aer subject of the reported event was not provided.The dsd edge units are not under steris service agreement for maintenance activities.The user facility is, and was at all relevant times, responsible for all maintenance activities.It is unknown if the employee subject of the reported event was wearing proper ppe at the time of the reported event as stated in the safety data sheets.The rapicide pa part a sds provides the following warning language and guidance, related to skin/inhalation exposure and ppe usage: "harmful if inhaled.May cause respiratory irritation.Causes severe skin burns.Symptoms may include redness, pain, blisters.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.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." a follow-up mdr will be submitted should additional information become available.

Event Description

An employee of the user facility alleged in a lawsuit that he was exposed to rapicide pa high-level disinfectant from their dsd edge aer due to a failure in the facility's drainage system.Complaint includes a report of injury (skin exposure/inhalation/irritation).

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Type of Device: 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
• MDR Report Key: 17080635
• MDR Text Key: 316711902
• Report Number: 2150060-2023-00031
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

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
• Device Operator: Health Professional
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1