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

Model Number	8110-12LV
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Wound Infection (2447)
Type of Reportable Event	Malfunction
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 09 dec 2025 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 incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 9611594-2025-00312 for the first report it was reported, the feeding tube balloon burst within six weeks postop.Per additional information received on 20nov2025, a new tube was inserted under general anesthesia.The patient has many postoperative problems with a wound infection due to the above problem.
Additional Manufacturer Narrative
The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 07 jan 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 21 cfr 803, 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.
Additional Manufacturer Narrative
Additional information: d4, h4, h6.The device history record for lot 30359854 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The device could not be filled with the suggested amount of water due to an apparent axial splitting of the balloon fabric.A root cause could not be determined.All information reasonably known as of 03 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 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 SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 23761485
• Report Number: 9611594-2025-00313
• Device Sequence Number: 21352125
• Product Code: KNT
• UDI-Device Identifier: 10350770445592
• UDI-Public: (01)10350770445592(240)120001501(11)250326(17)280325(10)30359854
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

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: Lay User/Patient
• Device Model Number: 8110-12LV
• Device Catalogue Number: 8110-12LV
• Device Lot Number: 30359854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/23/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 14 KG