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

Model Number ML02-0117

Device Problem Insufficient Information (3190)

Patient Problem Skin Discoloration (2074)

Event Date 10/13/2023

Event Type  malfunction  

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 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.

• 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 ; 4403927453
• MDR Report Key: 18103784
• MDR Text Key: 327757157
• Report Number: 2150060-2023-00047
• Device Sequence Number: 1
• Product Code: FEB
• 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: 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
• Device Operator: Health Professional
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1