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

Model Number ML02-0117

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 02/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

An automated endoscope reprocessor (aer) operator at the facility reported exposure symptoms of irritation to the eyes and nose when medivators rapicide pa high-level disinfectant leaked onto the floor.Medivators field service engineer visited the facility to service the aer.The drain hose was secured as this was assumed to be the cause for the leak.There are no risks of improper reprocessing due to this issue.It was reported that no additional medical attention was sought for the exposure symptoms.This complaint will continue to be maintained within medivators complaint system.

Event Description

An automated endoscope reprocessor operator at the facility reported exposure symptoms of irritation to the eyes and nose when medivators rapicide pa high-level disinfectant leaked onto the floor.

• 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 5491907
• MDR Text Key: 40044577
• Report Number: 2150060-2016-00012
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/09/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/10/2016
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: DSD EDGE