MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC BOLUS GASTROSTOMY FEEDING TUBE WITH ENFIT® CONNECTOR-14 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	8110-14LV
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the second of three reports.Refer to 9611594-2024-00252 for the first event.Refer to 9611594-2024-00254 for the third event.It was reported there was slipping of the external retention device causing the balloon to move post pyloric and cause obstruction.The device was inserted (b)(6)2024.There was an issue noted with disc slipping at 2-week post-op follow-up (telehealth).Then 15-days later disc noted to be at 8cm and adjusted.Then 2-weeks later again due for change to button but noted disc unable to be reduce to less than 4cm.Not changed to button due to concerns with tract formation due to slipping disc early on.Required barium and not to use device." additional information received (b)(6)2024 stating the patient was "sent for peg [percutaneous endoscopic gastrostomy] o-gram to check for leak and nil by peg.The patient's is unknown but assumed to be well.The device remains in use.
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 (b)(6)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 30261968, 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 31-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 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 BOLUS GASTROSTOMY FEEDING TUBE WITH ENFIT® CONNECTOR-14 FR
• 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20678198
• Report Number: 9611594-2024-00253
• Device Sequence Number: 12860809
• Product Code: KNT
• UDI-Device Identifier: 00350770445601
• UDI-Public: (01)00350770445601(240120001502(11)230530(17)260529(10)30261968
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K842076
• 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
• Report Date (Section B): 01/31/2025

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
• Device Expiration Date: 05/29/2026
• Device Model Number: 8110-14LV
• Device Catalogue Number: 8110-14LV
• Device Lot Number: 30261968
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 14 YR
• Patient Sex: Male
• Patient Weight: 42 KG