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	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was discovered that the employee subject of the reported event was splashed in the eye while disposing a bottle of rapicide.It was learned that the employee was not wearing the proper ppe, specifically eye protection, while handling rapicide.The root cause of this event is attributed to user error.Following the reported event, the user facility was provided with a copy of the safety data sheet for rapicide pa high level disinfectant.The safety data sheet for rapicide pa high level disinfectant states, "safety glasses or goggles are recommended when using product." user facility personnel were counseled on the proper use of the rapicide pa high-level disinfectant, specifically proper disposal instructions.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee was inadvertently splashed in the eye while handling rapicide resulting in a "burning sensation." the employee sought medical treatment at the emergency room; however, user facility personnel did not disclose what medical treatment was administered.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: RAPICIDE
• 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: 20158979
• Report Number: 2150060-2024-00044
• Device Sequence Number: 8259399
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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 Expiration Date: 11/04/2025
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Device Lot Number: (10)626436
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Date Device Manufactured: 05/06/2024
• 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