MAUDE Adverse Event Report: MEDIVATORS INC MINNCARE HD; DISINFECTANT

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has requested the distributor obtain additional information from the user facility to obtain the lot number for the device subject of the event.The distributor reported that the customer has not responded to these requests.It is unknown if the employees were wearing proper ppe at the time of the event.The minncare hd instructions for use (ifu) states, "personal protective equipment (ppe), handlers must wear: goggles or face shield, and protective rubber gloves." the ifu states, "corrosive.Causes irreversible eye damage.Harmful if absorbed through skin.Do not get in eyes, on skin, or on clothing.Avoid contact with skin." the ifu states, "if inhaled move person to fresh air.If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible, call a poison control center or doctor for further treatment advice." no additional issues have been reported.
Event or Problem Description
The user facility reported that their minncare hd was dropped during transfer causing the bottle to split and an employee was sent to employee health for inhalation/irritation.It is unknown if medical treatment was sought or administered.

• Brand Name: MINNCARE HD
• 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: 19298981
• Report Number: 2150060-2024-00030
• Device Sequence Number: 5665460
• Product Code: NIH
• UDI-Device Identifier: 00677964066870
• UDI-Public: 00677964066870
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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: 04/06/2023
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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