MAUDE Adverse Event Report: AVANOS MEDICAL INC. NEOMED FEEDING TUBE WITH ENFIT CONNECTOR; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2023

Event Type  Injury  

Event Description

It was reported via fda maude adverse event report mw18386277, on (b)(6) 2023: abdominal x-ray demonstrating massive pneumoperitoneum.Peritoneal drain placed at the bedside.On (b)(6) 2023: down trending platelet count.Exploratory laparotomy with creation of ostomy and mucus fistula.Generalized dusky bowel but no necrosis; on (b)(6) 2023: nitric oxide started.On (b)(6) 2023: hypotension requiring dopamine end fluid boluses.Severe acidosis noted.On (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 [necrosis] noted with 10 cm of ileum resected.

Manufacturer Narrative

H6: health effect - clinical code: appropriate term / code not available; pneumoperitoneum, down trending platelet count, acidosis, dusky bowel.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.A root cause could not be determined.All information reasonably known as of 12 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical 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.H3 other text: device not returned.

• Brand Name: NEOMED FEEDING TUBE WITH ENFIT CONNECTOR
• 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, cn 31512 1; CH 315121
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18705215
• MDR Text Key: 335407512
• Report Number: 3011270181-2024-00018
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American