MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ENTERAL FEEDING TUBE; DH EF PERC PLACEMENT PRODUCTS

Model Number	UNKNOWN
Medical Device Problem Codes	Burst Container or Vessel (1074); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that a balloon gastrostomy tube failed within 24-hours of radiologically inserted gastrostomy (rig) procedure.There was no reported injury additional information received 17-oct-2025 stated "rig procedure completed on (b)(6) 2025, cns [clinical nurse specialist] nutrition review the following day and the gastrostomy tube had displaced and fell out of the gastrostomy tract when the dressing was removed on (b)(6) 2025.New gastrostomy tube sited and contrast study performed to confirm gastric position under fluoroscopic guidance.Patient discharged and well.".
Additional Manufacturer Narrative
The sample is reportedly available for this complaint but was not returned when this report was filed.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-nov-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, 30365071, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample device was evaluated.The molded head, tube and balloon appeared to have a slight discoloration on the exterior and interior of the device.The original packaging was not returned with the device.The device could not be filled with the suggested amount of water due to an apparent axial direction u-shaped split that extends from the medial portion of the balloon (towards distal end area) up to the other side of balloon (towards distal tip) side of the device.The balloon was inspected under magnification, and the jagged edges were identified at the splitting when the balloon was manually pressed together in order to reform the balloon shape.The incident reported was confirmed via the sample evaluation.Root cause could not be determined.All information reasonably known as of 05-feb-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 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 actual complaint product was returned for evaluation.All information reasonably known as of 31-dec-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: UNKNOWN ENTERAL FEEDING TUBE
• Common Device Name: DH EF PERC PLACEMENT 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: 23547928
• Report Number: 9611594-2025-00276
• Device Sequence Number: 9283994
• Product Code: KNT
• UDI-Device Identifier: 00350770445601
• UDI-Public: (01)00350770445601(240)120001502(11)250521(17)280520(10)30365071
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNKNOWN
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 01/06/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/31/2025; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 56 KG