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

Model Number ML02-0117

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

Patient Problems Skin Irritation (2076); Chemical Exposure (2570)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

It was reported a biomed at the facility spilled rapicide pa part a between their index finger and thumb when adding rapicide pa to their automated endoscope reprocessor.The biomed experienced some irritation.The biomed called medivators to report the incident, medivators technical service read the safety measures on the rapicide pa safety data sheet.The biomed flushed their hand with water.It is unknown if the user was wearing personal protective equipment.The medivators safety data sheet, instructions for use, and label all instructs the users to wear protective gloves when handling rapicide pa part a.This complaint will continue to be monitored in the medivators complaint system.

Event Description

It was reported a biomed at the facility was exposed to rapicide pa part a between their index finger and thumb.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447 ; 7635533349
• MDR Report Key: 7895460
• MDR Text Key: 120965244
• Report Number: 2150060-2018-00062
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 09/20/2018

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: Other
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/20/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other