MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	40978
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to pass wire through the opaque/white portion of the equipment.

• Brand Name: HALYARD
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 widward parkway; alpharetta GA 30004
• MDR Report Key: 7533236
• Report Number: 7533236
• Device Sequence Number: 1065061
• Product Code: KNT
• UDI-Device Identifier: 10680651409789
• UDI-Public: (01)10680651409789
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/12/2018
• Report Date (Section F): 05/12/2018

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: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: 40978
• Device Catalogue Number: 7170-20
• Device Lot Number: 0202833884
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2018
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Date Report Sent to FDA: 05/12/2018