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

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Fedex freight reported via chemtrec report that a carrier employee was handling a damaged bottle of rapicide pa high-level disinfectant and obtained burns on their fingers.The carrier employee washed their hands with water and was advised to seek medical treatment should his symptoms worsen or not improve.
Additional Manufacturer Narrative
Through follow-up with the carrier employee, it was disclosed that bottles of rapicide pa high-level disinfectant became damaged in transit due to impact by other freight located in the carrier's vehicle.To date, steris has not been informed of this event directly from the user facility.The lot number subject of the event was not provided.Should additional information become available, a follow-up report will be submitted.No additional issues have been reported.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• 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: 17657646
• Report Number: 2150060-2023-00041
• Device Sequence Number: 20414202
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/30/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/30/2023
• 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