MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) CORFLO NASOGASTRIC / NASOINTESTINAL FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	20-9431
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tachycardia (2095); Low Oxygen Saturation (2477); Foreign Body In Patient (2687)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was intubated and primary nurse and i was inserting a small bowel feeding tube.The initial tube had the end piece as i examined prior to insertion, and after patient coughed, the tube was removed, and i noticed the tip was missing.Patient spo2 dropped, became tachycardic, called dr.(b)(6) with fear of a piece of the small bowel feeding tube was lodged in the lungs.Dr.(b)(6) did a bronchoscopy at bedside, had to use a glidescope with magill, found the tip of the small bowel feeding tube on the outside of the endotracheal tube and above vocal cords.Several attempts were made with piece of, and trauma to the nares and back of throat was noted with bleeding.Tubing set recovered and isolated.Vendor and manufacturer to be notified.Fda safety report id# (b)(4).

• Brand Name: CORFLO NASOGASTRIC / NASOINTESTINAL FEEDING TUBE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 11965440
• Report Number: MW5101759
• Device Sequence Number: 4015355
• Product Code: KNT
• UDI-Device Identifier: 00350770457932
• UDI-Public: (01)00350770457932
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2025
• Device Model Number: 20-9431
• Device Lot Number: 30100696
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR