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

Model Number ML020115

Device Problem Leak/Splash (1354)

Patient Problem Headache (1880)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

The user facility reported that employees at the user facility experienced headaches while being near a room with rapicide pa high level disinfectant.It was found that one of the boxes of product was placed upside down by the delivery service causing the product to leak out into the box.The leaking product was moved outside.

Manufacturer Narrative

The investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.Rapicide pa part a is bottled with a vented lid to allow chemical fumigation.The outer packer labeling indicates that the package be stored in an upright position during transit and storage.The following language is from the rapicide pa label, "store upright in shipping carton.Store unused portion in original container.Never tamper with vent.".

Manufacturer Narrative

Based on the description of the event, the root cause is attributed to the delivery provider incorrectly delivering the product upside down.The delivery provider has been notified of the issue to prevent recurrence.Rapicide pa part a is bottled with a vented lid to allow chemical fumigation.The outer packer labeling indicates that the package be stored in an upright position during transit and storage.The following language is from the rapicide pa label, "store upright in shipping carton.Store unused portion in original container.Never tamper with vent." 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: 18936027
• MDR Text Key: 338670603
• Report Number: 2150060-2024-00020
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/19/2024

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
• Device Model Number: ML020115
• Device Catalogue Number: ML020115
• Device Lot Number: 23000846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2023
• 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