MAUDE Adverse Event Report: MEDIVATORS RAPICIDE PA HIGH LEVEL DISINFECTANT

Model Number ML02-0117

Device Problem Use of Device Problem (1670)

Patient Problem Chemical Exposure (2570)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

A facility reported that an employee experienced exposure symptoms, burning eyes and throat, to rapicide pa high level disinfectant (hld).The employee sought medical attention.Medivators field service engineer (fse) was dispatched to observe the facility's work flow.The fse confirmed their reported improper disposal of the chemistry.They were not following the hld ifu.The fse recommended additional in-service training.Medivators regulatory contacted the facility to follow up.The nurse manager reported that the employee who had experienced exposure to the rapicide pa hld fumes was wearing gloves, but no other personal protective equipment (ppe).No treatment was given, and the employee is reported to be doing fine.The facility did not reference the sds.No one else was exposed.

Event Description

A facility reported that an employee experienced exposure symptoms, burning eyes and throat, to rapicide pa high level disinfectant (hld).The employee sought medical attention.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis, mn
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th ave n; minneapolis, mn
• Manufacturer Contact: laurie weir ; 9800 59th ave n; minneapolis, mn ; 8984328
• MDR Report Key: 9695057
• MDR Text Key: 189766910
• Report Number: 2150060-2020-00007
• 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: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/11/2020

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: No Information
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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