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

Model Number	8100-14LV
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "we had another burst balloon last week - 3 days post insertion.Patient had 14fr mic bgt inserted as a new tube (b)(6) 2026.Patient called hotline due to tube falling out (b)(6) 2026.Attended a&e, enplug placed by a&e staff as it was the weekend enplug not placed all the way into the stoma, stoma had already closed halfway down.Patient required another rig insertion (b)(6) 2026." the stoma site was established (b)(6) 2026.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.The device could not be filled with the suggested amount of water due to an apparent radial direction split of the balloon fabric at the proximal collar area of the device.The device history record for lot 30365085 was reviewed and the product was produced according to product specifications.A root cause could not be determined.All information reasonably known as of 27 feb 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.

• Brand Name: MIC 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 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 ; 4704485487
• MDR Report Key: 24470917
• Report Number: 9611594-2026-00083
• Device Sequence Number: 9581768
• Product Code: KNT
• UDI-Device Identifier: 00350770442914
• UDI-Public: (01)00350770442914(240)120001492(11)250521(17)280520(10)30385035
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8100-14LV
• Device Catalogue Number: 8100-14LV
• Device Lot Number: 30365085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG