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

Model Number	0120-18-1.7
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Granuloma (1876); Pain (1994); Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Event or Problem Description
The parent reported leakage from the gastrostomy tube during use, with milk leaking onto the child.The child exhibited a red rash, discharge around the stoma, and possible old blood.Granulation tissue was present, and the managing physician had prescribed topical ointment.The child experienced pain each time the tube was cleaned.The parent adjusted the balloon fill volume from 10 milliliters to 5 milliliters in an attempt to reduce discomfort, but symptoms persisted.Leakage from the stoma continued, and the parent expressed concern that the issue may be related to the gastrostomy tube size or another underlying problem.The parent sought a second medical opinion.A mature stoma was reported.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 30366306 was reviewed and the product was produced according to product specifications.Sample was not returned for further evaluation of the potential defect; however, pictures were provided by the customer that confirms the reported incident.A root cause could not be determined.All information reasonably known as of 05 mar 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-KEY GASTROSTOMY (G) FEEDING TUBE KITS
• 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: 24521959
• Report Number: 9611594-2026-00115
• Device Sequence Number: 9691548
• Product Code: KNT
• UDI-Device Identifier: 00350770948843
• UDI-Public: (01)00350770948843(240)120002714(11)250528(17)270528(10)30366306
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0120-18-1.7
• Device Catalogue Number: 0120-18-1.7
• Device Lot Number: 30366306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 7 YR
• Patient Sex: Male