MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY (G) FEEDING TUBES; DH EF BALLOON TUBES PRODUCTS

Model Number	8110-14LV
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported ¿gastrostomy tube inserted on (b)(6) 2026.On (b)(6) 2026, dislocation due to tear in the balloon.¿ the device had been in use for 2 days when the balloon failure occurred, resulting in tube dislodgement.The patient experienced pain and required replacement of the gastrostomy tube, including an additional endoscopic procedure under intubation anesthesia.Intravenous antibiotics were administered.The patient¿s condition was reported as stable.
Additional Manufacturer Narrative
The device history record for lot 30362868 was reviewed and the product was produced according to product specifications.No sample was returned for evaluation; therefore, the reported balloon failure could not be confirmed or replicated, and no definitive cause was identified.All information reasonably known as of 06 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.

• Brand Name: MIC GASTROSTOMY (G) FEEDING TUBES
• 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: 24802368
• Report Number: 9611594-2026-00176
• Device Sequence Number: 21503403
• Product Code: KNT
• UDI-Device Identifier: 00350770445601
• UDI-Public: (01)00350770445601(240)120001502(11)250423(17)280422(10)30362868
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 8110-14LV
• Device Catalogue Number: 8110-14LV
• Device Lot Number: 30362868
• 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: 03/09/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2025
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 56 KG