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

Model Number ML02-0117

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/30/2022

Event Type  malfunction  

Event Description

The user facility reported that rapicide pa high-level disinfectant contacted an employee's hand while handling the product.The employee rinsed her hands with water and observed discoloration.It is unknown if medical treatment was sought or administered.

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

Through follow up with user facility personnel, it was confirmed that the employee subject of the reported event washed their hands with water and returned to work.

Manufacturer Narrative

The employee subject of the reported event was not wearing proper ppe while handling the rapicide pa high-level disinfectant.A steris district service manager counseled user facility personnel on the importance of wearing proper ppe.The user facility was provided a copy of the safety data sheet (sds) following the reported event.No additional issues have been reported.

• 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 n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16246459
• MDR Text Key: 308475064
• Report Number: 2150060-2023-00008
• 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,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1