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

Model Number ML02-0117

Device Problem Device Handling Problem (3265)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

A recycling plant reported via chemtrec report that a strong odor was detected coming from containers of rapicide pa high level disinfectant and several employees experienced inhalation/irritation.The employees moved to fresh air and their symptoms resolved.

Manufacturer Narrative

Per follow-up discussion with a recycling plant employee, it was determined that the bottles had not been properly disposed of by the end user as some of the bottles were still full of product.It is unknown from which end user or customer the bottles were collected from by the recycling plant.The safety data sheet was provided to the recycling plant.The safety data sheets states, "first-aid measures after inhalation: if inhaled, remove to fresh air." the rapicide pa high level disinfectant instructions for use states, "after use, ensure that all containers are rinsed per epa rcra guidelines.Dispose of any unused material to include containers per local, state and federal regulations." no additional issues have been reported.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Type of Device: 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: 18336255
• MDR Text Key: 330677201
• Report Number: 2150060-2023-00053
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML02-0117
• Device Catalogue Number: ML02-0117
• Device Lot Number: 586809
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1