MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICKEY GJTUBE XSET ENFIT,14FR,2.0CM,1; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-14-2.0-45
Medical Device Problem Codes	Burst Container or Vessel (1074); Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the jejunostomy tube was blocked.The caregiver attempted to unblock and felt a pop.Parent started feeding and leakage came through gastrostomy port.Large milk aspirates from gastrostomy so attended for change.Contrast showed tube perforation and jejunal tube completely blocked.
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 and udi number are in-progress.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.All information reasonably known as of 16-oct-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 device history record for the reported lot number, 30268247, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One used sample was received product packaging was not received.After cleaning and decontamination, the sample was examined in a well-lit area.There was brown buildup and/or discoloration throughout the tubing.A rupture in the tubing was not observed.Feeding was simulated using water.When infused into the jejunal port, the water exited from one of the gastric skives as well as from the jejunal skives.When infused into the gastric port, the water exited from one of the gastric skives.Occlusion was not experienced.The gastric skives were then examined under magnification.There was a crack/split in the inner septum between the gastric and jejunal lumens.There was dried, brown buildup on the septum.Root cause could not be determined.All information reasonably known as of 25-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 21 cfr 803, 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 GJTUBE XSET ENFIT,14FR,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: 19872191
• Report Number: 9611594-2024-00151
• Device Sequence Number: 7114838
• Product Code: KNT
• UDI-Device Identifier: 00350770470474
• UDI-Public: (01)00350770470474(240)104704701(11)230712(17)250711(10)30268247
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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 Expiration Date: 07/11/2025
• Device Model Number: 8270-14-2.0-45
• Device Catalogue Number: N/A
• Device Lot Number: 30268247
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 06/27/2025
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/16/2024; 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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 Age: 8 YR
• Patient Sex: Female