MAUDE Adverse Event Report: MEDIVATORS RAPICIDE GLUTARALDEHYDE; HIGH LEVEL DISINFECTANT

Model Number	ML02-0059
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/16/2016
Additional Manufacturer Narrative
Two nurses experienced exposure symptoms (headaches) to rapicide glutaraldehyde.It was reported that the nurses did not receive medical attention and the headaches subsided.One of the nurses was pregnant.Medivators environmental health and safety manager reached out to this facility to discuss their concerns.It was reported that the exposure was caused by changing out the filters in their dsd-201 automated endoscope reprocessor.The filters were left in the sink to allow remaining fluid to drain.They were not rinsed and the residual rapicide created fumes.Medivators provided literature on exposure while pregnant.No additional patient illness or injury reported.This complaint will continue to be monitored through medivators complaint handling procedure.
Event or Problem Description
The case states that two (2) nurses experienced chemical exposure symptoms from rapicide glutaraldehyde high level disinfectant.The exposure symptoms included headaches.

• Brand Name: RAPICIDE GLUTARALDEHYDE
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 5943677
• Report Number: 2150060-2016-00037
• Device Sequence Number: 19052093
• Product Code: MED
• UDI-Device Identifier: 00677964034855
• UDI-Public: 00677964034855
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K993042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 09/12/2016

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
• Operator of Device: No Information
• Device Model Number: ML02-0059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2016
• Initial Report FDA Received Date: 09/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DSD-201