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

Model Number ML02-0115

Device Problem Fracture (1260)

Patient Problems Arrhythmia (1721); Sore Throat (2396)

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

The disinfectant spill was cleaned up using a medivators disinfectant spill clean-up kit.No additional reports of adverse events or harm were received.The bottle subject of the event was not returned for evaluation.The exact cause of the reported bottle damage could not be determined; however, is likely the result of rough handling during shipping or by user facility personnel.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

Event Description

A user facility reported that a bottle of medivators rapicide pa part a had cracked and leaked into the facility's storage cabinet.When attempting to identify the source of the leak, a user inhaled the fumes and reported experiencing throat discomfort and an irregular heartbeat.The user was evaluated on-site at the facility; a chest x-ray was obtained but no additional medical intervention was reported.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• 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: daniel davy ; 9800 59th avenue; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 12565299
• MDR Text Key: 277764524
• Report Number: 2150060-2021-00019
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2021

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: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: ML02-0115
• Device Lot Number: 499026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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