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

Model Number	ML02-0117
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that two employees were exposed to skin and inhalation exposure after using the rapicide pa high-level disinfectant.This exposure caused a burning sensation to the employees' nose, eyes and throat.Report of a headache and whitening of skin was also reported.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
The lot of the reported product was not provided and the bottle subject of the reported event was not returned for evaluation.Through follow-up with user facility personnel, it was discovered that the rapicide was placed in a recycle bag after use, and the tie to the recycle bag had loosened.A small amount of rapicide within the bag had spilled causing fumes to generate.The first employee had directly touched the bag and had to flush their eyes in the eyewash station.The second employee thoroughly washed their hands with soap and water quickly resolving the issue.It was confirmed that ppe was not worn at the time of the time of the event, but was worn during cleanup.The rapicide pa part a safety data sheet provides the following warning language and guidance, related to skin exposure and ppe usage: "causes severe skin burns and eye damage.Wash hands thoroughly after handling.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): rinse skin with water/shower." medivators offered counseling on the importance of wearing proper ppe when handling rapicide pa high-level disinfectant; however, the user facility declined.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.

• 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: 18066615
• Report Number: 2150060-2023-00046
• Device Sequence Number: 7769186
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023; Not provided
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/30/2023; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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