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

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Low Blood Pressure/ Hypotension (1914); Internal Organ Perforation (1987); Hematuria (2558); Ascites (2596)

Event Date 10/18/2023

Event Type  Injury  

Event Description

Pt admitted on (b)(6) 2023 for extreme prematurity.A 5fr ogt placed on admission (lot unk).Donor human mild feeds started (b)(6) 2023.On (b)(6) 2023 6 fr ogt placed (22079138).On (b)(6)2023 surgery consulted for hematuria, hypotension; (b)(6) 2023 abdominal xray demonstrating portal venous gas.Abdominal ultrasound demonstrating abdominal perforation and ascites.Too unstable for surgical intervention at this time.On (b)(6) 2023: placement of peritoneal drain for nec and pneumoperitoneum.Liquified bowel evacuated during drain placement.On (b)(6) 2023, abdominal xray demonstrating persistent free intraperitoneal air.Exploratory laparotomy done as well as enterotomy closure of canal perforation, and ileostomy creation, drainage of intraabdominal abcess.

• 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: 18386082
• MDR Text Key: 331321513
• Report Number: 18386082
• 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?: 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 20 DA
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic