MAUDE Adverse Event Report: Avanos Medical Inc. MIC* Bolus Gastrostomy Feeding Tube with ENFit® Connector; DH EF Balloon Tubes Products

Model Number	8110-14LV
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	08/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent primary gastrostomy insertion with no immediate complications reported.The balloon was seen to be inflated at the end of the procedure.Two days later, he had a ct abdomen and pelvis due to acute abdominal pain that showed the balloon to be deflated and the gastrostomy was partially withdrawn (the tip was just within the stomach).That night, they exchanged the gastrostomy tube as an emergency case in ir.The balloon had ruptured.The tube was replaced, and the patient's pain eased quickly.
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record and udi are in-progress.All information reasonably known as of 28 sep 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)(6).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.

• Common Device Name: DH EF Balloon Tubes Products
• Manufacturer (Section D): Avanos Medical Inc.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (Avent 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50915853
• Report Number: 9611594-2026-00724
• Device Sequence Number: 12206653
• Product Code: KNT
• UDI-Device Identifier: 00350770445601
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 8110-14LV
• Device Catalogue Number: 8110-14LV
• Device Lot Number: 30390181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male