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

Model Number ML020115

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation into the reported event is in process; a follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee was handling a package of rapicide pa high level disinfectant that had leaked, and they experienced a "white substance" on their hands.Medical treatment was administered (ointment).

Manufacturer Narrative

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 dhr and retain samples were reviewed and no abnormalities were noted.There have been no other complaints with this lot.Rapicide pa part a is bottled with a vented lid to allow chemical fumigation.The following language is from the rapicide pa label, "store upright in shipping carton.Store locked up in original tightly, closed container - never tamper with vent." it is unknown if the chemistry bottle orientation was changed during transport or storage at the facility.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: 18399357
• MDR Text Key: 331823130
• Report Number: 2150060-2023-00056
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ML020115
• Device Catalogue Number: ML020115
• Device Lot Number: 23000561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2023
• 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