MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICKEY GTUBE XSET ENFIT,12FR,2.0CM,1; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-12-2.0
Medical Device Problem Code	Cross Reactivity (1137)
Health Effect - Clinical Codes	Purulent Discharge (1812); Pain (1994); Discomfort (2330)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "patient had ongoing issues with black exudate coming out of the stoma and pain.Ongoing problems with pain/discomfort/bloating/black discharge and bleeding.Frequent swabs taken - no current infection isolated." customer confirmed, "this is not a device issue." additional information received on 02-jul-2024 stated paracetamol and antibiotics were used to treat stoma.Additional information received on 03-jul-2024 stated the device was inserted on (b)(6) 2024.
Additional Manufacturer Narrative
The actual device is reported to be available but has not been 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 30-jul-2024 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 product involved in the report has been returned and is being processed for evaluation.A review of the device history record and udi number are in-progress.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, 30178185, 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, there were crusty and brownish foreign material, this was a non-production related incident.Since the device was in use for an extended period of time within 90+ days, which, indicated that device did not show this defect at time of placement and the tube performed as intended.For the feeding tube reaction it was not possible to determine the root cause of the reported issue.The complaint about reaction on the tissue was unable to be evaluated.The mickey device did not appear to have obvious defects.Per instructions for use (ifu) states the following information for stoma site: -selection of the correct size mic-key* is critical for the safety and comfort of the patient.Measure the length of the patient¿s stoma with the stoma measuring device (fig 1).The shaft length (fig 2-e) of the mic-key* selected should be the same as the length of the stoma.An inappropriately sized mic-key* can cause necrosis, buried bumper syndrome, and/or hypergranulation tissue.-clean the stoma site, use warm water and mild soap.Use a circular motion moving from the feeding tube outwards.Clean sutures, external base (fig 2-d), and any stabilizing devices using a cotton tipped applicator.Rinse thoroughly and dry well.Root cause could not be determined.All information reasonably known as of 18-sep-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: MICKEY GTUBE XSET ENFIT,12FR,2.0CM,1
• 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: 19872416
• Report Number: 9611594-2024-00150
• Device Sequence Number: 18049230
• Product Code: KNT
• UDI-Device Identifier: 00350770427164
• UDI-Public: (01)00350770427164(240)1098466603(11)220105(17)240105(10)30178185
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2024
• Device Model Number: 8140-12-2.0
• Device Catalogue Number: N/A
• Device Lot Number: 30178185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 08/21/2025
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/04/2024; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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 Age: 25 YR
• Patient Sex: Female
• Patient Weight: 30 KG