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

Model Number ML02-0117

Device Problems Fumes or Vapors (2529); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported rapicide pa high level disinfectant was spilled in an office.It was reported 3 people experienced chemical exposure from inhaling the fumes of the spilled hld.The facility contacted the (b)(6) emergency number, obtained the safety data sheet, and evacuated all personnel from the area.The fire department cleaned the spill using neutralizer.Medivators regulatory affairs has made several attempts to contact the initial reporter with no success.It is unknown how the spill occurred and if the exposed personnel experienced any symptoms from inhaling the fumes.The current condition of the exposed personnel is also unknown.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported rapicide pa high level disinfectant spilled and 3 people experienced chemical exposure to the hld fumes.

• 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: 7186757
• MDR Text Key: 97123554
• Report Number: 2150060-2018-00005
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other