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 Abnormal Blood Gases (1034); Abscess (1690); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Hematuria (2558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported via fda mw report mw18386082/mw5150579 the following information: pt admitted on (b)(6) 2023 for extreme prematurity.A 5fr ogt placed on admission (lot unk).Donor human mild feeds started (b)(6) 2023.On (b)(6) 2023 6 fr ogt placed (22079138).On (b)(6)2023 surgery consulted for hematuria, hypotension; (b)(6) 2023 abdominal x-ray demonstrating portal venous gas.Abdominal ultrasound demonstrating abdominal perforation and ascites.Too unstable for surgical intervention at this time.On (b)(6) 2023: placement of peritoneal drain for nec and pneumoperitoneum.Liquified bowel evacuated during drain placement.On (b)(6) 2023, abdominal x-ray demonstrating persistent free intraperitoneal air.Exploratory laparotomy done as well as enterotomy closure of canal perforation, and ileostomy creation, drainage of intraabdominal abscess.

Manufacturer Narrative

Health effect - clinical code: 4819: pneumoperitoneum.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 14-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.

• 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: 18712653
• MDR Text Key: 335529317
• Report Number: 9611594-2024-00019
• 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
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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
• 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): Life Threatening; Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic