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

Model Number ML02-0117

Device Problems Component Falling (1105); Fumes or Vapors (2529)

Patient Problems Respiratory Distress (2045); Chemical Exposure (2570)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported that while transporting rapicide pa high level disinfectant on a cart, the bottle fell and the hld spilled.It was reported that a closing door hit the cart which caused the hld bottle to fall to the floor and broke the cap off the bottle.Approximately 4 cups of solution spilled before the staff member upended the bottle.No one came in direct contact with the spilled solution.The 12-15 people were reported to have potentially inhaled the fumes from the spill.The facility contacted the chemtrec emergency number, obtained the safety data sheet, and evacuated all staff and patients from the area.The area was cleaned using the manufacturer-recommended neutralizer.Three (3) nurses reported experiencing respiratory related symptoms from the spilled hld solution, 2 of which received treatment by a doctor.It was confirmed that all staff are now back at work with no recurring symptoms.The facility is continuing to monitor the affected staff members.

Event Description

A facility reported that while transporting rapicide pa high level disinfectant on a cart, the bottle fell and the hld spilled.Three (3) facility staff reported experiencing chemical exposure symptoms including respiratory symptoms.

• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7165383
• MDR Text Key: 96405588
• Report Number: 2150060-2018-00003
• 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: health professional,other,use
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/04/2018

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/04/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other