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

Model Number ML020117

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sore Throat (2396)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

User facility stated that the shipping box had some moisture/residue present but was unable to confirm any seal damage to the rapicide bottle.It was noted that upon receival, the shipping box appeared damaged but was disposed of without further investigation.The safety data sheet for rapicide includes inhalation warnings to not breathe in dust/fume/gas/mist/vapors/spray while handling the disinfectant.Due to insufficient information, a root cause cannot be determined.A follow-up mdr will be submitted should additional information become available.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained an irritated throat after "inhaling fumes" while opening a box of rapicide pa high level disinfectant.The user facility disclosed that medical treatment was sought but not administered.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Type of Device: 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: 18962003
• MDR Text Key: 338616899
• Report Number: 2150060-2024-00022
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML020117
• Device Catalogue Number: ML020117
• Device Lot Number: 610755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2024
• 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