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

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2023

Event Type  Injury  

Event Description

(b)(6) 2023: abdominal x-ray demonstrating massive pneumoperitoneum.Peritoneal drain placed at the bedside.(b)(6) 2023: downtrending platelet count.Exploratory laparotomy with creation of ostomy and mucus fistula.Generalized dusky bowel but no necrosis; 10/17/2023: nitric oxide started.On 10/18/2023: hypotension requiring dopamine end fluid boluses.Severe acidosis noted.(b)(6) 2023: laparotomy, ostomy takedown with temporary abdominal closure via silo.Continues on dopamine, dobutamine and epinephrine for blood pressure support.On (b)(6) 2023: silo removed, nec noted with 10cm of ileum resected.

• 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: 18386277
• MDR Text Key: 331298391
• Report Number: 18386277
• 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: 11/17/2023,11/27/2023

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
• Event Location: Hospital
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 26 WK
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American