MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS; NEOMED FEEDING TUBE WITH ENFIT CONNECTOR

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 11/10/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 patient was admitted for extreme prematurity (24 weeks) and extremely low birthweight (0.690 grams).On (b)(6) 2023 5fr ogt placed on admission for decompression; (b)(6) 2023 trophic feeds initiated at 2ml every 6 hours via ogt.On (b)(6) 2023 morning xrays benign; (b)(6) patient with frequent apnea and bradycardia and declining mean blood pressures, made npo, septic workup initiated; (b)(6) 2023 at 1209 left lateral decubitus xray showed free intraperitoneal air; (b)(6) 2023 surgical consult and penrose drain placed.(b)(6) 2023 ex lap performed with right hemicolectomy, resection of terminal ileum, resection of jejunum and creation of ostomy.

• Brand Name: AVANOS
• Type of Device: NEOMED FEEDING TUBE WITH ENFIT CONNECTOR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward pkwy; alpharetta GA 30004
• MDR Report Key: 18386268
• MDR Text Key: 331298108
• Report Number: 18386268
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2023,11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2023
• Distributor Facility Aware Date: 11/17/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American