MAUDE Adverse Event Report: MEDIVATORS INC MINNCARE HD; DISINFECTANT

Lot Number	542248
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
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 understand the root cause of the leak.The distributor reported that the customer has not responded to these requests.Based on the description of the event, it is likely that the leak was caused by damage during shipping.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 on skin or on clothing take off contaminated clothing.Rinse skin immediately with plenty of water for 15-20 minutes.Call a poison control center or doctor for treatment." no additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a burn on their hand requiring medical treatment while handling a leaking box of minncare hd.Two other employees were reported to have a minor injury during clean up from the leak; the details of the injury are unknown.

• 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: 19298980
• Report Number: 2150060-2024-00029
• Device Sequence Number: 20250241
• 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
• Device Lot Number: 542248
• 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
• Date Device Manufactured: 04/01/2022
• 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