MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the first of two reports.Refer to 9611594-2025-00191 for the second event.It was reported the suture "anchor wires are breaking." there was no reported injury.Additional information received 05-aug-2025 stated no medical intervention was required.
Additional Manufacturer Narrative
The sample is reportedly available for this complaint but was not returned.A review of the device history record and udi number are in-progress.All information reasonably known as of 27-aug-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-ehc-25-00724.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, 30302423, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.A tray with some loose sutures, soft shells and needle/ cannula assembly was returned in the lab.No original packaging received however, a product label sticker was returned.The sample was evaluated and confirmed that the sutures were damaged.However, the dhr from this lot number was evaluated from the manufacturing, process evaluation and tools are in right conditions and there were no activities that could identified the cause of this type of damage in this particular device incident, therefore, the root cause could not be determined.All information reasonably known as of 20-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.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR
• 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: 22913342
• Report Number: 9611594-2025-00190
• Device Sequence Number: 21096123
• Product Code: KGC
• UDI-Device Identifier: 00350770984322
• UDI-Public: (01)00350770984322(240)109843206(11)240117(17)250912(10)30302423
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080253
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 09/12/2025
• Device Model Number: 98432
• Device Catalogue Number: 98432
• Device Lot Number: 30302423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2024
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 55 KG