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

Model Number	8140-12-3.0
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 30372311 was reviewed and the product was produced according to product specifications.Sample was not available for evaluation; therefore, functional testing could not be performed to confirm or duplicate the reported incident.Root cause could not be determined.It was not possible to determine the cause of the reported tube dislodgement without a returned sample for evaluation.Review of manufacturing records and process controls did not identify abnormalities associated with the reported failure mode.All information reasonably known as of (b)(6) 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.
Event or Problem Description
The customer reported that a feeding tube was found dislodged while the patient was residing in a care home.Attempts to reinsert a replacement tube were unsuccessful, and the patient was transferred for further medical management.Endoscopic intervention was subsequently performed and a replacement percutaneous endoscopic gastrostomy (peg) tube was inserted.The patient was reported to be stable following treatment.Additional follow-up information reported "i presume a new stoma tract was made, as the patient previously had a 12fr, and now has a 16fr, however its in roughly the same location in the abdomen.".

• 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: 25332503
• Report Number: 9611594-2026-00379
• Device Sequence Number: 9880891
• Product Code: KNT
• UDI-Device Identifier: 00350770427218
• UDI-Public: (01)00350770427218(240)104272102(11)250729(17)270723(10)30372311
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 8140-12-3.0
• Device Catalogue Number: 8140-12-3.0
• Device Lot Number: 30372311
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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: 25 YR
• Patient Sex: Female