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

Model Number ML02-0117

Device Problem Shipping Damage or Problem (1570)

Patient Problem Eye Pain (4467)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

The user facility reported that their rapicide pa high-level disinfectant was damaged during delivery.Upon delivery, the courier experienced eye irritation and discoloring to their hands while handling the rapicide pa high-level disinfectant.The courier washed their hands with water.

Manufacturer Narrative

Following the reported event, the rapicide pa high-level disinfectant was left outside for disposal.User facility personnel contacted the local fire department and hazmat for proper disposal of the product.The reported event is attributed to damage that the rapicide pa high-level disinfectant sustained during transit to the user facility.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: 16204207
• MDR Text Key: 307689822
• Report Number: 2150060-2023-00006
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Device Lot Number: 567364
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/19/2023
• Date Device Manufactured: 12/08/2022
• 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