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 Codes	Vomiting (2144); Eye Irritation (4803)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was disclosed that the user facility had received the incorrect product.The product received was ml02-0117 instead of ml02-0059.Upon receiving the incorrect product, the user facility contacted steris customer service.Steris advised user facility personnel to dispose of the product and that the correct product would be shipped.No additional issues have been reported.
Event or Problem Description
The user facility reported that while employees were disposing of rapicide pa high-level disinfectant they began to vomit and experienced shortness of breath, eye, and skin irritation.The employees washed their arms with water and were sent to the emergency room.The subject employees were discharged from the emergency room the same day.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid information.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: 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: 17915956
• Report Number: 2150060-2023-00043
• Device Sequence Number: 6636634
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619(11)230630(17)241217(10)589639
• 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
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2024
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Device Lot Number: (10)589639
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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