MAUDE Adverse Event Report: AVANOS MEDICAL AVANOS; NEOMED FEEDING TUBE

Device Problem Insufficient Information (3190)

Event Date 10/12/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 pt admitted to unit secondary to extreme prematurity (25 weeks); (b)(6) 2023 ogt placed for decompression on admission; (b)(6) 2023 at 1500 feeds initiated with dhm 2cc every 6 hours - received 2 feeds; (b)(6) 2023 at 0337 cxr for ett and lines showed massive pneumoperitoneum; left lateral "decubitus xray at 0345 showed massive pneumoperitoneum, pt made npo and surgery consult done.On (b)(6) 2023 penrose drain placed at bedside.On (b)(6) 2023 exploratory laparotomy and creation of ostomy and mucous fistula done.

• Brand Name: AVANOS
• Type of Device: NEOMED FEEDING TUBE
• Manufacturer (Section D): AVANOS MEDICAL; 5405 windward pkwy; alpharetta GA 30004
• MDR Report Key: 18386062
• MDR Text Key: 331291514
• Report Number: 18386062
• 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

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: 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
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American