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

Model Number ML02-0117

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Contrary to the reported event, the user facility confirmed that the bottle of rapicide pa high level disinfectant did not explode; user facility personnel used inflammatory language to describe the reported event.During the time of the reported event, the employee was in the process of placing the bottle of rapicide pa high level disinfectant on top of a shelf when the product leaked out of the bottle subsequently contacting the employee.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee was moving their inventory of rapicide pa high level disinfectant and the bottle "exploded" in her face.The employee was sent to the er and received medical treatment.

Manufacturer Narrative

The rapicide pa part a high level disinfectant safety data sheet states, "hand protection: wear chemically resistant protective gloves.Eye protection: wear approved eye protection (properly fitted dust- or splash-proof chemical safety goggles) and face protection (face shield).Skin and body protection: wear suitable protective clothing.Wear solvent resistant apron and boots for spills." the user facility reported that the cap liner was not in place on the rapicide pa part a high level disinfectant resulting in the reported event.Medivators requested pictures of the cap or for the cap to be returned for evaluation; however, the user reported that pictures and the cap were not available for evaluation.There have been no other complaints associated with this lot.No additional issues were reported.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

• 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: 18263692
• MDR Text Key: 330669147
• Report Number: 2150060-2023-00049
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ML02-0117
• Device Lot Number: 597750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2023
• 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