MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC BOLUS GASTROSTOMY FEED TUBE WITH ENFIT CONNECTOR-18 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	8110-18
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported patient had a radiologically inserted gastrostomy (rig) inserted on the (b)(6) 2025, patient complained to severe abdominal pain around noon time on the (b)(6) 2025.Gastrostomy feeding tube was slightly dislodged.[computed tomography] ct scan was done and confirmed abdominal leak of stomach fluids in between the muscle of the abdominal wall.A new avanos mic bolus 18fg gastrostomy feeding tube was inserted, balloon inflated with 8ml contrast/saline.Previous avanos mic bolus 18fg gastrostomy feeding tube was kept on the sterile set up and [the physician], tested the balloon and injected saline and evident 'tear' was visible as saline just leaked immediately." patient "complained of pain and felt unwell, risk of inflammation/infection, repeated procedure was required including additional radiation dose and medical intervention required rig exchange repeated procedure, [intravenous antibiotics] monitoring, current patient status reported as well." additional information received 13-oct-2025 stated no "further information on the patient demographics" was available.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of (b)(6) 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 event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30350123, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The reported sample device was evaluated.The molded head, tube and balloon appeared to have some discoloration on the exterior and interior of the device.The original packaging was not returned with the device.The device could not be filled with the suggested amount of water due to an apparent axial splitting of the balloon fabric.The split was extending from the base of the balloon to the distal tip of the device.The balloon fabric was inspected under magnification, and a notch/tab was identified in the medial location of the balloon material.Root cause could not be determined.All information reasonably known as of 30-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 event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.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 FEED TUBE WITH ENFIT CONNECTOR-18 FR
• 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: 23384092
• Report Number: 9611594-2025-00250
• Device Sequence Number: 8689841
• Product Code: KNT
• UDI-Device Identifier: 00350770445625
• UDI-Public: (01)00350770445625(11)241207(17)271127(10)30350123
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 8110-18
• Device Catalogue Number: 8110-18
• Device Lot Number: 30350123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2024
• 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 Sex: Unknown