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

Device Problem Insufficient Information (3190)

Patient Problems Skin Discoloration (2074); Abdominal Distention (2601)

Event Date 11/04/2023

Event Type  Death  

Event Description

(b)(6) 2023 patient admitted to nicu for extreme prematurity (22 weeks and 2 days) and extremely low birth weight (0.460 grams); (b)(6) 2023 5 fr ogt placed on admission for decompression; (b)(6) 2023-(b)(6) 2023 patient remained npo.On (b)(6) 2023 (midnight) abdominal 2 view xray done for abdominal discoloration and distention showed questionable portal venous air; (b)(6) 2023 peritoneal drain placed by surgery.(b)(6) 2023 pt made allow natural death; (b)(6) 2023 1042 pt expired.Refer to add'l documents in i2k.

• 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: 18349674
• MDR Text Key: 330752909
• Report Number: 18349674
• 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: 12/13/2023,11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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): Death; Required Intervention; Life Threatening
• Patient Age: 7 DA
• Patient Sex: Female
• Patient Race: Black Or African American