MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT-24 FR-PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	0644-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
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 second of two reports.Refer to 3006646024-2025-00024 for the first event.It was reported the guidewire caused damage to the plastic cone and the guidewire consequently broke off.The physician was able to remove the peg [percutaneous endoscopic gastrostomy] without causing any injury, and the patient is doing well.Additional information received 23-jul-2025 stated "the doctor did the loop in the peg with [the] wire and pull[ed] as always the plastic part rip[ped] off" but it was more closer to the plastic part.There was no injury to the patient.
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 14-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 (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: MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT-24 FR-PULL
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22815113
• Report Number: 3006646024-2025-00025
• Device Sequence Number: 5713352
• Product Code: KNT
• UDI-Device Identifier: 00350770958309
• UDI-Public: (01)00350770958309(240)120001436(11)250221(17)270221(10)30355397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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 Model Number: 0644-24
• Device Catalogue Number: 0644-24
• Device Lot Number: 30355397
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown