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

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Electrolyte Imbalance (2196); Hematuria (2558); Lethargy (2560); Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/17/2023

Event Type  Death  

Event Description

Pt admitted to the nicu on (b)(6) 2023 for extreme prematurity; 5 fr ogt (lot unk) placed on admission and feeds of donor human milk started on (b)(6) 2023.On (b)(6) 2023, ogt replaced with a 6.5 fr ogt (lot ty230404).On (b)(6) 2023, ogt replaced with a 5 fr ogt (lot ty230214).On (b)(6) 2023, ogt replaced with 5 fr ogt (lot ty230214).On (b)(6) 2023, ogt replaced with 5 fr ogt (lot ty230214).On (b)(6) 2023, ogt replaced with 5 fr ogt (lot ty 230113).On (b)(6) 2023, ogt replaced with 6 fr ogt (lot 170323ff).On (b)(6) 2023: abdominal x-ray obtained for emesis and abdominal distention.Benign, continued with feeds.On (b)(6) 2023 1126: acute decompensation with hyperglycemia, metabolic acidosis and hypercarbia with increased ventilator settings on the hfjv.Pt lethargic and dusky on exam with bloody stool and firm, distended and tender abdomen.At 1145: abdominal xray demonstrating pneumatosis, portal venous air consistent with necrotizing enterocolitis; 1202: abdominal x-ray demonstrating pneumatosis and portal venous air; 1904: evacuation of pneumoperitoneum via peritoneal drain placement at the bedside.Pt on insulin drip.On (b)(6) 2023 - (b)(6) 2023: pt continued to be acidotic, hypotensive and hyperglycemic with increased ventilator settings.Received epinephrine drip.Ffp and prbc transfusion completed for continued frank stools and hematuria, low platelet count.On (b)(6) 2023 0847: surgery evacuated add'l air from peritoneum via q-tip for persistent pneumoperitoneum on abdominal x-ray.Pt made an "and"; 1032: pt held and electively extubated.Time of death: 1032.Refer to add'l doduments in i2k.

• Brand Name: AVANOS NEOMED FEEDING TUBE WITH ENFIT CONNECTOR
• Type of Device: NEOMED FEEDING TUBE WITH ENFIT CONNECTOR
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward pkwy; alpharetta GA 30004
• MDR Report Key: 18350219
• MDR Text Key: 330755837
• Report Number: 18350219
• 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: 12/18/2023
• 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: 12/12/2023
• Distributor Facility Aware Date: 12/17/2023
• Event Location: Hospital
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 25 WK
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White