MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEED TUBE KIT EXTENSION SETS-22 FR, 1.5 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-22-1.5-45
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 health effect - clinical code/4581 - appropriate term / code not available: minor bleeding.The device history record for the reported lot number, 30360667, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.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)(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
It was reported the patient believes tube size is too small.The patient was unable to get a gauze between the abdomen and the tube and there was bleeding.The patient plans to see physician for sizing.Additional information received (b)(6) 2025 stating the patient was "treated for infection with about 20-days of oral antibiotics for a respiratory infection suspected to be caused from aspirating during that procedure plus the gj [gastrojejunal] stoma site [which] looked infected too after its placement likely due to its improper size.It has continued to bleed intermittently and has granulation tissue that is inflamed but doesn't look infected anymore." the patient was scheduled for a (b)(6) 2025 device replacement related to sizing.

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEED TUBE KIT EXTENSION SETS-22 FR, 1.5 CM
• 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: 22868860
• Report Number: 9611594-2025-00186
• Device Sequence Number: 21056400
• Product Code: KNT
• UDI-Device Identifier: 00350770441245
• UDI-Public: (01)00350770441245(240)104412401(11)250326(17)270326(10)30360667
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: Lay User/Patient
• Device Model Number: 8270-22-1.5-45
• Device Catalogue Number: 8270-22-1.5-45
• Device Lot Number: 30360667
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 45 KG