MAUDE Adverse Event Report: MEDIVATORS DEFENDO DISPOSABLE AIR/WATER VALVE; DISPOSABLE AIR/WATER VALVE FOR GI ENDOSCOPES

Model Number	100310
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medivators account manager reported a facility reprocessing, then reusing defendo disposable air/water, suction, and biopsy valves between uses in patient procedure.The defendo air/water, suction and biopsy valve is intended for single use, thus potential for patient cross-contamination.The medivators account manager was at the facility for an in-service and observed a tech at the facility reprocess defendo air/water, suction and biopsy valves in their dsd 201 automated endoscope reprocessor.The account manager noted that the facility had been reprocessing a sample box of these valves that he had given to the facility three months previous at which they were informed of appropriate use of the product.The facility has been informed that the valves cannot be reprocessed and need to be disposed of after every use.The facility is still reprocessing and reusing the valves.There are no reports of any patient harm at the facility.This complaint will be continued to be monitored in the medivators complaint system.
Event or Problem Description
A medivators account manager reported a facility reprocessing, then reusing defendo disposable air/water, suction, and biopsy valves between uses in patient procedure.The defendo air/water, suction and biopsy valve is intended for single use, thus potential for patient cross-contamination.

• Brand Name: DEFENDO DISPOSABLE AIR/WATER VALVE
• Common Device Name: DISPOSABLE AIR/WATER VALVE FOR GI ENDOSCOPES
• Manufacturer (Section D): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 7598694
• Report Number: 1651395-2018-00001
• Device Sequence Number: 19151890
• Product Code: ODC
• UDI-Device Identifier: 00677964052453
• UDI-Public: 00677964052453
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K102409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 100310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other