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

Model Number	ML02-0115
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Arrhythmia (1721); Sore Throat (2396)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HIGH-LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 12565299
• Report Number: 2150060-2021-00019
• Device Sequence Number: 1140796
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: ML02-0115
• Device Lot Number: 499026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1