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

Model Number ML02-0117

Device Problems Leak/Splash (1354); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that two employees were exposed to skin and inhalation exposure after using the rapicide pa high-level disinfectant.This exposure caused a burning sensation to the employees' nose, eyes and throat.Report of a headache and whitening of skin was also reported.It is unknown if medical treatment was sought or administered.

Manufacturer Narrative

The lot of the reported product was not provided and the bottle subject of the reported event was not returned for evaluation.Through follow-up with user facility personnel, it was discovered that the rapicide was placed in a recycle bag after use, and the tie to the recycle bag had loosened.A small amount of rapicide within the bag had spilled causing fumes to generate.The first employee had directly touched the bag and had to flush their eyes in the eyewash station.The second employee thoroughly washed their hands with soap and water quickly resolving the issue.It was confirmed that ppe was not worn at the time of the time of the event, but was worn during cleanup.The rapicide pa part a safety data sheet provides the following warning language and guidance, related to skin exposure and ppe usage: "causes severe skin burns and eye damage.Wash hands thoroughly after handling.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): rinse skin with water/shower." medivators offered counseling on the importance of wearing proper ppe when handling rapicide pa high-level disinfectant; however, the user facility declined.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 north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18066615
• MDR Text Key: 327303016
• Report Number: 2150060-2023-00046
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 11/30/2023
• 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