MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC BOLUS GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR; DH EF BALLOON TUBES PRODUCTS

Model Number	8110-16LV
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abnormal Blood Gases (1034); Septic Shock (2068); Peritonitis (2252)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 30367135 was reviewed and the product was produced according to product specifications.The root cause was not able to be established.All information reasonably known as of 02 apr 2026 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.
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidents, which were associated with separate units, involving one patient.This is the second of two reports.Refer to 9611594-2026-00167 for the first report.It was reported that a "patient had a new gastrostomy tube inserted, as replacement, on (b)(6) 2026, with radiological control.On the morning of (b)(6) 2026, while enteral feeding was being resumed, a state of hypovigilance occurred.Hemodynamics were stable.There was diffuse abdominal contracture.Arterial blood gas analysis revealed a normal ph but hyperlactatemia at 9 mmol/1.An emergency abdominal ct scan revealed poor positioning of the gastrostomy balloon, which ended in the omental fat, with the presence of a sheet of hemoperitoneum spreading into the douglas pouch and supramesocolic pneumoperitoneum.The patient is transferred to the medical intensive care unit and then taken over by the digestive surgery team on the same day.Peritonitis in all four quadrants was confirmed with the presence of enteral feeding fluid associated with false membranes in the pelvis.The gastrostomy tube was found in the free peritoneum and not in the stomach.Immediately after surgery, antibiotic therapy was changed to tazocillin and linezolid.Peritoneal fluid samples remained sterile.This digestive complication resulted in the diagnosis of probable septic shock, requiring the prescription of noradrenaline and hydrocortisone hemisuccinate.All enteral nutrition was suspended and, after a central line was placed, parenteral nutrition was started.During the three days spent in the intensive care unit, the onset of spinal scar separation was observed.".

• Brand Name: MIC BOLUS GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; circuito industrial no.40; colonia obrera; nogales 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 24765645
• Report Number: 9611594-2026-00168
• Device Sequence Number: 10299345
• Product Code: KNT
• UDI-Device Identifier: 00350770445618
• UDI-Public: (01)00350770445618(240)120001513(11)250611(17)280610(10)30367135
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8110-16LV
• Device Catalogue Number: 8110-16LV
• Device Lot Number: 30367135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 61 KG