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

Model Number ML02-0117

Device Problem Fumes or Vapors (2529)

Patient Problem Chest Tightness/Pressure (2463)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported that an employee inhaled rapicide pa high level disinfectant (hld) fumes and became sick.The employee was treated at the hospital due to the reported chemical exposure.Medivators regulatory followed up with the facility and it was reported that the chemical exposure occurred when the employee walked into the scope decontamination room where the empty rapicide pa solution bottle had been processed.It is unknown if the employee was wearing the appropriate personal protective equipment (ppe).They reported experiencing symptoms including tightness in the chest, difficulty breathing, and wheezing.The individual was treated with steroids and bronchodilators.They confirmed that the employee did not have lasting symptoms and they did not miss any time from work.It is a health and safety requirement for facilities to have a minimum of 10 air changes per hour in the reprocessing room to minimize staff exposure to chemical vapors.The rapicide pa labeling and sds also instruct users to avoid breathing fumes and to wear ppe when handling.The facility evaluated the ventilation in the room and reported that the room was ventilated properly.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported that an employee inhaled rapicide pa high level disinfectant (hld) fumes and became sick.

• 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 INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: laurie weir ; 14605 28th ave n; minneapolis, MN 55447 ; 7638984320
• MDR Report Key: 9445162
• MDR Text Key: 184317591
• Report Number: 2150060-2019-00071
• 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: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• 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