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

Model Number	ML02-0117
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Headache (1880)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee experienced a headache after being exposed to rapicide.The employee did not seek medical treatment and continued working.
Additional Manufacturer Narrative
While onsite, a steris service technician discovered that rapicide was leaking in a storage room.The leak was quickly contained by user facility personnel.The cause of the leak was due to improper stacking of the rapicide bottles.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." while onsite, the technician counseled user facility personnel on the proper handling and storage of rapicide as well as wearing the proper ppe.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.
Additional Manufacturer Narrative
While onsite, the technician counseled user facility personnel on the proper handling of rapicide.No additional issues have been reported.

• 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: 20429849
• Report Number: 2150060-2024-00050
• Device Sequence Number: 8420185
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/29/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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