MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS-16 FR, 1.7CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-16-1.7-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the, "jejunal feeds exited into stomach, noted after tube had been in place for over 7-months." the device was initially inserted on (b)(6) 2024.There was no reported injury.
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 16-jan-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.
Event or Problem Description
Additional information received 28-jan-2025 stating the patient, "required a general anesthetic for change of tube" and was transferred to another facility for access for intravenous (iv) fluids.The patient was admitted for three nights to the health facility.
Additional Manufacturer Narrative
Additional information.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 27-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.
Additional Manufacturer Narrative
Correction d4: lot #30270863.The device history record for the reported lot number, 30270863, 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.The product packaging was not received.After cleaning and decontamination, the sample was examined in a well-lit area.It appeared in generally clean condition.The tri-lumen tubing was examined under magnification.There were no tears, cuts or holes in the outer wall of the tubing.The gastric skives were examined.The proximal-most skive has a tear in the inner septum, which separates the gastric lumen from the jejunal lumen.Feeding was simulated using water.When fed through the jejunal port, the water exited the gastric skives, due to the tear.Root cause could not be determined.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 comp-(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 GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS-16 FR, 1.7CM
• 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: 21172588
• Report Number: 9611594-2025-00010
• Device Sequence Number: 4336556
• Product Code: KNT
• UDI-Device Identifier: 00350770440859
• UDI-Public: (01)00350770440859(240)104408501(11)230726(17)250725(10)30270863
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

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: 07/25/2025
• Device Model Number: 8270-16-1.7-30
• Device Catalogue Number: 8270-16-1.7-30
• Device Lot Number: 30270863
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 04/29/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/27/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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
• Patient Weight: 45 KG