MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY G-FEED TUBE, EXTENSION SETS, ENFIT, 14 FR, 2 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-14-2.0
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tube was inserted in mid-(b)(6) exact date unknown.The patient presented to the hospital on the (b)(6) 2024 with the balloon unable to be deflated through the balloon port.The provider tried to inflate but no success."tried to push the balloon port in with a paperclip to release with no success.White balloon port became detached from the mic-key g tube.Cut mic-key tube below the low-profile button.The water within the ballon did not appear to release and ballon fell through the stoma.The patient had "multiple presentations with several x-rays but nothing was showing and then discovered on the (b)(6) 2025 through ct [computed tomography] scan showed inflated gastrostomy balloon identified in ileum.Serous ascites evident.On delivery of bowel with laparotomy balloon slid more proximally so enterotomy was made in jejunum.Proximal bowel distended and hemorrhagic, but no ischemic bowel seen.Surgery on the (b)(6) 2025 longitudinal enterotomy in jejunum and ballon delivered, closure 4.0 pds [polydioxanone sutures] interrupted transversely.Bowel returned to abdomen.Went to hdu [high dependency unit] post-op on antibiotics for 48-hours.Ngt [nasogastric tube] and gastrostomy both to drainage bags aspirate ngt 4-hours.".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 05-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, 30256386, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 28-may-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 G-FEED TUBE, EXTENSION SETS, ENFIT, 14 FR, 2 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21537328
• Report Number: 9611594-2025-00048
• Device Sequence Number: 20596856
• Product Code: KNT
• UDI-Device Identifier: 00350770427317
• UDI-Public: (01)00350770427317(240)104273102(11)230503(17)250502(10)30256386
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: Health Professional
• Device Expiration Date: 05/02/2025
• Device Model Number: 8140-14-2.0
• Device Catalogue Number: 8140-14-2.0
• Device Lot Number: 30256386
• Was Device Available for Evaluation?: No
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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: Male