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

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that the employee was handling the rapicide with nitrile gloves and spilled the product on their gloves while changing bottles into the aer's interior cabinet.The product subsequently reached the employee's hands, causing the reported event.The following language related to safe handling of the rapicide pa high-level disinfectant can be found on the sds, "causes skin irritation.Symptoms may include redness, edema, drying, defatting and cracking of the skin.Wash hands thoroughly after handling.Wear protective gloves/eye protection/face protection.If on skin: wash with plenty of water.Take off contaminated clothing and wash it before reuse.If skin irritation occurs: get medical advice/attention." the rapicide pa part a sds 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." no additional issues have been reported.

Event Description

The user facility reported that an employee received "minor burns" on their hands from rapicide pa high level disinfectant.The employee washed their hands until symptoms were resolved.

• 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: 18769005
• MDR Text Key: 336989836
• Report Number: 2150060-2024-00011
• 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: 02/23/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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