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

Model Number ML02-0117

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

The dhrs for the subject lot were reviewed and no abnormalities were found.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." the user facility was counseled on the importance of ppe during handling of rapicide pa high-level disinfectant.No additional issues have been reported.

Event Description

The user facility reported that an employee was handling a box of rapicide pa high-level disinfectant part a, upon receipt the bottles were packed upside down causing a burn on an employee's hand.The employee washed the affected area and returned back to work.The employee was reported to not have been wearing gloves at the time of the event.No additional reports of injury were reported.No medical treatment was sought or 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 ; 14605 28th ave n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16106426
• MDR Text Key: 308068221
• Report Number: 2150060-2023-00003
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ML02-0117
• Device Catalogue Number: ML020117
• Device Lot Number: 558234
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Date Device Manufactured: 08/29/2022
• 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