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

Model Number	ML02-0117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was moving a bottle of rapicide pa high level disinfectant and some of the bottle contents "squirted out" of the lid towards the employee's face.No report of injury.
Additional Manufacturer Narrative
Medivators contacted the user facility to obtain additional information regarding the event.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The rapicide pa part a high level disinfectant safety data sheet states, "hand protection: wear chemically resistant protective gloves.Eye protection: wear approved eye protection (properly fitted dust- or splash-proof chemical safety goggles) and face protection (face shield).Skin and body protection: wear suitable protective clothing.Wear solvent resistant apron and boots for spills." the user facility reported that the cap liner was not in place on the rapicide pa part a high level disinfectant resulting in the reported event.Medivators requested pictures of the cap or for the cap to be returned for evaluation; however, the user reported that pictures and the cap were not available for evaluation.There have been no other complaints associated with this lot.No additional issues were reported.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid information.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: HIGH LEVEL 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: 18335077
• Report Number: 2150060-2023-00051
• Device Sequence Number: 8489278
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619(11)230823(17)250211(10)596148
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/15/2023

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: 02/11/2025
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Device Lot Number: (10)596148
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023; Not provided
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/29/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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