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

Model Number ML02-0117

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

To date, steris has not been informed of this event directly from the user facility.The lot number subject of the event was not provided.It is unknown if the employees subject of the reported event were wearing proper ppe at the time of the reported event as stated in the safety data sheets.The rapicide pa high-level disinfectant safety data sheets provides the following precautionary statements, avoid breathing dust/fume/gas/mist/vapours/spray.Use only outdoors or in a well ventilated area.Wash hands thoroughly after handling.Wear protective gloves/eye protection/face protection.In case of inadequate ventilation wear respiratory protection.The safety data sheets further provides the following language and guidance related to inhalation, toxic if inhaled.May cause allergy or asthma symptoms or breathing difficulties if inhaled.May cause respiratory tract irritation.Should additional information become available, a follow up report will be submitted.No additional issues have been reported.

Event Description

The user facility reported via chemtrec report that rapicide pa high level disinfectant, part a, was spilled onto the floor by an inventory clerk while stocking the product.Two (2) employees responded to the chemical spill and were reported to be exposed to the disinfectant and experienced inhalation/ irritation.Medical treatment was sought.The user facility did not disclose if medical treatment was administered.

• 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 ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 16682761
• MDR Text Key: 312704376
• Report Number: 2150060-2023-00021
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• 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
• Type of Report: Initial
• Report Date: 04/05/2023

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 Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/05/2023
• 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