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

Catalog Number ML02-0117

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Nausea (1970)

Event Date 06/29/2015

Event Type  No Answer Provided  

Event Description

The facility reported a strong odor when changing the rapicide pa high-level disinfectant containers in their medivators dsd edge automated endoscope reprocessor (aer).The staff reported experiencing exposure symptoms of headache and nausea.

Manufacturer Narrative

The facility reported a strong odor when changing the rapicide pa high-level disinfectant containers in their medivators dsd edge automated endoscope reprocessor (aer).The staff reported experiencing exposure symptoms of headache and nausea.Medivators sales representative advised the site on how to properly change the disinfectant containers and dispose of the used containers to minimize exposure to the disinfectant.It is unclear if the staff at the site were using the proper ppe.It was also reported they had recently purchased the aers and had switched from opa (which has no scent) to peracetic acid based rapicide pa high-level disinfectant.There is no information regarding the handlers' current status, effects of exposure symptoms or if medical attention was sought.The sales representative continues to be in contact with the site.This complaint will continue to be monitored through medivators complaint handling system.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• 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: 4944072
• MDR Text Key: 6634821
• Report Number: 2150060-2015-00020
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/27/2015

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: Medical Assistant
• Device Catalogue Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/27/2015
• 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: DSD EDGE AER