MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE; 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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "on (b)(6) 2025, a child underwent a gpe insertion with an introduction kit.She returned to the ward on (b)(6) 2025 because two anchors had become detached after her return home.As the anchors had to remain in place for at least ten days, she was taken back to the operating theatre the same day to have three anchors put back in urgently, with the use of an additional gastrointestinal anchoring kit.The clinical consequences were a second operation under general anaesthetic two days apart.This is a recurring incident in the department." per additional information received on 7may2025, a second operation was performed to reposition the anchors.There were no known negative consequences.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 30342466 was reviewed and the product was produced according to product specifications.A root cause could not be determined.All information reasonably known as of 27 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint comp (b)(4) 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
• 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 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22100035
• Report Number: 9611594-2025-00114
• Device Sequence Number: 7390213
• Product Code: KGC
• UDI-Device Identifier: 00350770984322
• UDI-Public: (01)00350770984322(240)109843206(11)240918(17)260821(10)30342466
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: 08/21/2026
• Device Model Number: 98432
• Device Catalogue Number: 98432
• Device Lot Number: 30342466
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 12 KG