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

Model Number	100305
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators sales representative was informed by the medical director at the facility a disposable defendo valve had been reprocessed in their automated endoscope reprocessor and reused in a patient procedure.There is potential for patient cross-contamination because the defendo valves are intended for and labeled as single use only.Medivators ra informed the facility the product is not validated for reuse and cannot confirm the product had been disinfected.There have been no reports of patient illness.This complaint will continue to be monitored within the medivators complaint handling system.
Event or Problem Description
The facility reported reprocessing and reusing a disposable defendo valve in a patient procedure.The defendo valve is intended for single use and thus there is 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 INC.; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 6886561
• Report Number: 1651395-2017-00003
• Device Sequence Number: 495905
• Product Code: ODC
• UDI-Device Identifier: 00677964060250
• UDI-Public: 00677964060250
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,user f
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: 100305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/22/2017
• 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