MAUDE Adverse Event Report: MEDIVATORS RAPICIDE PA; HIGH LEVEL DISINFECTANT

Model Number ML02-0117

Device Problem Fumes or Vapors (2529)

Patient Problem Chemical Exposure (2570)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that employees experienced exposure symptoms from rapicide pa high level disinfectant (hld).It was reported the materials management team at the facility was moving rapicide pa onto storage shelves when they noticed a case was leaking onto the floor.They used rags to clean it up, then moved the leaking case out of the storage room and into a public hallway.The fumes from the leaking case caused employees symptoms of respiratory irritation.It was reported the employees sought medical attention for their symptoms.The materials management team did not follow the instructions for use to properly clean up the spill.It was reported they were also not wearing the proper protective equipment.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

It was reported that employees experienced exposure symptoms from rapicide pa high level disinfectant (hld).

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447 ; 7635533349
• MDR Report Key: 8001556
• MDR Text Key: 124956861
• Report Number: 2150060-2018-00067
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/25/2018

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: No Information
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other