MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN NEOMED NGT; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number UNKNOWN

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 Type  Death  

Manufacturer Narrative

Health effect - clinical code/no code: necrotizing enterocolitis and pneumatosis and portal venous air.Death-1802.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 15-feb-2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

Event Description

It was reported via mw report mw18350219 received on 18-jan-2024, and the following was received: 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 x-ray 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'i 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'i documents in i2k.".

• Brand Name: UNKNOWN NEOMED NGT
• Type of Device: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.; no.788,mozhi north rd; tourism resort; dongqian lake, ningbo zhejiang 31512 1; CH 315121
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18726568
• MDR Text Key: 335619292
• Report Number: 3011270181-2024-00022
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Life Threatening
• Patient Age: 7 DA
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White