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

Model Number	46037
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We have had two events this week.In the first event, the distal end of an ng tube, measuring approximately 2.5 inches, was found in a patient's stool.The remaining part of the ng tube that was still in the patient was subsequently removed.An x-ray showed no evidence of any radiopaque fragment that was retained in the patient.It is unclear when exactly the tip of the ng tube broke off.In the second event involving a different patient, the ng tube was clogged and then removed.The ng tube was not fragmented inside the patient, as in the first case, but there was similar damage to the tube seen upon inspection.A segment of the ng tube had ballooned out but did not break apart.

• Brand Name: HALYARD
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9956928
• Report Number: 9956928
• Device Sequence Number: 3130855
• Product Code: KNT
• UDI-Device Identifier: 10680651460377
• UDI-Public: (01)10680651460377
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2020
• Report Date (Section F): 04/08/2020

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 Model Number: 46037
• Device Catalogue Number: 40-8368
• Device Lot Number: 30015580
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2020
• 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: 04/08/2020