MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY JEJUNAL FEEDING TUBE KIT, EXTENSION, ENFIT CONCTR 18 FR, 1.2CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8230-18-1.2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The lot number was not provided by the customer.All information reasonably known as of 13-feb-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 that tube "is leaking profusely"- leaking around tube from stoma- and that he is getting "burns on my belly because of the gastric juices leaking; rating discomfort '7-8' due to the skin irritation.States md [medical doctor] has advised him leakage is normal but [patient] is now changing gauze underneath [every] 30-40 min due to leakage.States has wound care rn [registered nurse] at home 3 times/[week] and she is helping manage the irritated areas.Reports has edema as comorbidity; advised that this may be affecting sizing for tube.Per [patient], md has not checked actual stoma length but changed internal diameter of tube last year." additional information received 06-feb-2025 stated it is believed "the valve came apart in tube and that is why it leaked- reports 'it was squirting water' when syringe was disconnected and losing up to 2-3 ml daily.States that replacement tube has been functioning without issue thus far.".
Additional Manufacturer Narrative
Additional information: d4.All information reasonably known as of 26-mar-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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30332908, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The subject sample provided was evaluated related to the incident reported by customer and no failures were detected in the device returned; unable to confirm or duplicate the reported incident.Root cause could not be determined.All information reasonably known as of 02-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 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-KEY JEJUNAL FEEDING TUBE KIT, EXTENSION, ENFIT CONCTR 18 FR, 1.2CM
• 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: 21380150
• Report Number: 9611594-2025-00027
• Device Sequence Number: 12835247
• Product Code: KNT
• UDI-Device Identifier: 00350770441603
• UDI-Public: (01)00350770441603(240)104416001(11)240626(17)260626(10)30332908
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K853197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/05/2026
• Device Model Number: 8230-18-1.2
• Device Catalogue Number: 8230-18-1.2
• Device Lot Number: 30332908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 06/03/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/27/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male