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 01/05/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported 500 ml of rapicide pa high level disinfectant spilled.It was reported that fumes were inhaled and individuals not wearing proper personal protective equipment (ppe) experienced chemical exposure on their skin.There was an immediate response from the facility and the spill was cleaned according to the safety data sheet.Medivators environmental health and safety manager contacted the facility and provided information regarding proper ventilation and employee exposure monitoring, as requested.Medivators regulatory affairs also followed up with the facility and received confirmation that exposed staff did not have lasting exposure symptoms.The facility plans to address their concerns for ensuring proper air exchanges/ventilation in their space as well as possibly implementing a badge test for staff working in the area where the fumes were present.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported 500 ml of rapicide pa high level disinfectant spilled.It was reported that fumes were inhaled and individuals not wearing proper personal protective equipment (ppe) experienced chemical exposure on their skin.The facility requested information regarding proper ventilation and employee exposure monitoring.

• 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: 7234044
• MDR Text Key: 98781966
• Report Number: 2150060-2018-00007
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other