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

Model Number	8100-14LV
Medical Device Problem Codes	Deflation Problem (1149); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
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 9611594-2025-00334 for the first report.It was reported, ¿the department reports two cases of malfunctioning sng probes that deflated spontaneously.In both situations, images taken at the end of the procedure confirm that the probes were correctly positioned." "patient 2: the second patient ended up with the tube, with the balloon deflated, outside the stoma.The balloon had clearly not been tested to verify its integrity.No complications were reported for this case.".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 30359841 was reviewed and the product was produced according to product specifications.All information reasonably known as of 23 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.
Additional Manufacturer Narrative
All information reasonably known as of 19 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 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 FEEDING TUBE WITH ENFIT CONNECTORS
• 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: 23882492
• Report Number: 9611594-2025-00335
• Device Sequence Number: 17320081
• Product Code: KNT
• UDI-Device Identifier: 00350770442914
• UDI-Public: (01)00350770442914(240)104603602(17)290225(10)30359841
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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: 8100-14LV
• Device Catalogue Number: 8100-14LV
• Device Lot Number: 30359841
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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 Sex: Unknown