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 09/17/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Employees at facility complained of exposure symptoms of running eyes, nausea, running nose, congestion, headache and voice change while working with rapicide pa high level disinfectant.A medivators field service engineer (fse) was at the facility and noted that the employees were throwing rapicide pa disinfectant test samples into a trash receptacle instead of properly disposing of the samples down the drain.The fse advised the facility on the proper means of test sample disposal, which is down a sink drain followed by rinsing of the container before disposal.Medivators environmental health and safety manager followed up with the facility and advised how to properly dispose of disinfectant samples and empty disinfectant bottles.She also educated them on the importance of proper ventilation, bottle storage and wearing ppe while handling rapicide pa.Since the discussion and fse visit, the employees are doing fine and there have been no additional reports of exposure symptoms, injury or illness.There is limited information as to whether employees sought additional medical attention.This complaint will continue to be maintained within medivators complaint system.

Event Description

Employees at facility complained of chemical exposure symptoms of running eyes, nausea, running nose, congestion, headache and voice change while working with rapicide pa high level disinfectant.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 5141707
• MDR Text Key: 27971535
• Report Number: 2150060-2015-00031
• Device Sequence Number: 1
• Product Code: FEB
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Report Date: 10/09/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDIVATORS ADVANTAGE PLUS AER