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

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapicide pa high-level disinfectant bottle subject of the reported event was disposed of by user facility personnel and is not available for evaluation.Without the return and evaluation of the product, the cause of the event could not be determined.The user facility was unable to provide the lot number for the rapicide pa high-level disinfectant; therefore, a review of the device history record and complaint review could not be performed.The steris account manager has made multiple attempts to obtain additional information regarding the event however, the user facility could not provide further information.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that a bottle of rapicide pa high-level disinfectant allegedly "exploded" while an employee was handling the product.The employee went the emergency department and was placed through the decontamination shower.It is unknown if the employee sought or received additional medical treatment.
Additional Manufacturer Narrative
Steris obtained additional information regarding the reported event.User facility personnel confirmed that the rapicide pa high-level disinfectant bottle was bulging during handling and contrary to the initial report did not "explode".When the employee opened the bottle in the sink, the rapicide pa high-level disinfectant leaked out contacting the employee who was not wearing proper ppe.The employee obtained "burns" to their arms, neck, and face and went to the emergency department.It is unknown if the employee received additional medical treatment.The rapicide instructions for use states, "harmful in contact with skin.Causes severe skin burns and eye damage.Harmful if inhaled.May cause respiratory irritation.Precautionary statements: do not breathe dust/fume/gas/mist/vapors/spray.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): take off immediately all contaminated clothing.Rinse skin with water/shower." a steris account manager offered in-service training on the proper use and handling of rapicide pa high-level disinfectant; however, the user facility declined.No additional issues have been reported.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 23085889
• Report Number: 2150060-2025-00028
• Device Sequence Number: 10484983
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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