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

Model Number ML02-0117

Device Problem Leak/Splash (1354)

Patient Problem Vomiting (2144)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

Through follow-up with user facility personnel, it was disclosed that the user facility had received the incorrect product.The product received was ml02-0117 instead of ml02-0059.Upon receiving the incorrect product, the user facility contacted steris customer service.Steris advised user facility personnel to dispose of the product and that the correct product would be shipped.No additional issues have been reported.

Event Description

The user facility reported that while employees were disposing of rapicide pa high-level disinfectant they began to vomit and experienced shortness of breath, eye, and skin irritation.The employees washed their arms with water and were sent to the emergency room.The subject employees were discharged from the emergency room the same day.

• 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 north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 17915956
• MDR Text Key: 326284398
• Report Number: 2150060-2023-00043
• 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
• Report Date: 10/11/2023

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
• Device Operator: Health Professional
• Device Model Number: ML02-0117
• Device Lot Number: 589639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1