MAUDE Adverse Event Report: MEDIVATORS, INC. RAPICIDE PA HIGH-LEVEL DISINFECTANT

Model Number ML02-0117

Device Problem Device Handling Problem (3265)

Patient Problem Burn(s) (1757)

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

The employee stated to the steris account manager that he was changing the rapicide pa high level disinfectant from one of their endoscope processors when the reported event occurred.The account manager stated that the reported event may be attributed to the chemical change process that employees are performing.The account manager is scheduled to perform in-service training on the proper use and handling of rapicide pa high level disinfectant.Investigation of this event is in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee obtained a burn to their fingers after handling rapicide pa high level disinfectant.The employee was sent to the er.

Manufacturer Narrative

Through follow-up, user facility personnel stated there was no visible damage to the rapicide pa high level disinfectant container and that no leaks were present.The employee subject of the reported event stated that there may have been a tear in the glove that she was wearing while handling the rapicide pa high level disinfectant however, the glove was not available to confirm the tear.The account manager performed in-service training on the proper use and handling of rapicide pa high level disinfectant.No additional issues have been reported.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Type of Device: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 15717340
• MDR Text Key: 304878399
• Report Number: 2150060-2022-00047
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• 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