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

Model Number ML02-0117

Device Problems Component Falling (1105); Chemical Spillage (2894)

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported that an employee experienced exposure to rapicide pa part a high level disinfectant while transporting a bottle of hld on a cart.It was reported the bottle fell off the cart and broke, causing the hld solution to splash on the employee's leg.The exposed personnel immediately flushed the exposed skin and went to the facility's employee health center to monitor the burning symptoms.No further medical treatment was required and the affected personnel is reported to be fine.The facility used the product safety data sheet and spill kit to clean up the spilled hld.The facility's logistics department is educating its staff on proper handling and storage of related products.Medivators will continue to monitor this complaint within medivators complaint handling system.

Event Description

The facility reported that while an employee was transporting a bottle of rapicide pa part a high level disinfectant, the bottle fell off a cart and broke causing the hld to splash on her leg.The exposed personnel experienced chemical exposure and burning symptoms from the hld.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7009352
• MDR Text Key: 91347742
• Report Number: 2150060-2017-00047
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other