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

Model Number	8110-14LV
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, ¿mic bolus 14fr gastrostomy balloon burst this morning.The rig was inserted (b)(6) 2025 with 4mls of sterile water, this is a new stoma site not a replacement.¿ per additional information received on 3jul2025, ¿the individual is currently an inpatient, the medical team were alerted and reviewed the patient.Pain relief was provided, an enplug was inserted and replacement tube.¿ no issues with tube replacement.
Additional Manufacturer Narrative
The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record and udi are in-progress.All information reasonably known as of 21 jul 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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30329949, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample was evaluated.The molded head, tube and balloon appeared to have slight 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 radial direction split of the balloon fabric.There were jagged edges identified at the area of splitting, after the balloon material was manually pressed together in order to reform the balloon shape.The split goes around the balloon near the proximal collar area of the device.The balloon was inspected under magnification (20x).Root cause could not be determined.All information reasonably known as of 24-oct-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 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: 22563857
• Report Number: 9611594-2025-00156
• Device Sequence Number: 9283127
• Product Code: KNT
• UDI-Device Identifier: 00350770445601
• UDI-Public: (01)00350770445601(240)120001502(11)240611(17)270611(10)30329949
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 8110-14LV
• Device Catalogue Number: 8110-14LV
• Device Lot Number: 30329949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 73 KG