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

Model Number 46037

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2020

Event Type  malfunction  

Event 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9956928
• MDR Text Key: 187550039
• Report Number: 9956928
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651460377
• UDI-Public: (01)10680651460377
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 46037
• Device Catalogue Number: 40-8368
• Device Lot Number: 30015580
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1