MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD; GENERAL SURGERY TRAY (KIT)

Model Number	92794
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
There was a hole in the wall suction set that prevented the fluid from being suctioned.Due to this, another kit had to be opened to complete the procedure.

• Brand Name: HALYARD
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7482673
• Report Number: 7482673
• Device Sequence Number: 11191696
• Product Code: LRO
• UDI-Device Identifier: 10680651927948
• UDI-Public: (01)10680651927948
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2018
• Report Date (Section F): 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2018
• Device Model Number: 92794
• Device Catalogue Number: 61450
• Device Lot Number: 0202857718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/30/2018