MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG KIT WITH ENFIT CONNECTOR; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number	50-6516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the peg [percutaneous endoscopic gastrostomy] tube "inner fixation stop came loose from the tubing when trying to pull it out/traction remove." the device was in use for six months.Additional information received 17-dec-2024 noted the clinician left "stop plate in place and informed the patient of the symptoms to watch out for." additional information received (b)(6) 2024 12-19 noted the patient was "good when left the clinic, living at home.".
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided the actual device is reported to be available but has not been returned for evaluation.All information reasonably known as of 10-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.
Additional Manufacturer Narrative
The sample was not received with the original packaging.Upon receipt of the sample, only the tubing was received, no other components of the tube were returned.There were jagged edges on both ends of the tubing, the end towards the bumper and end towards the y-adaptor when viewed under magnification (20x).Components such as tube fixation device, pinch clamp, bumper and y-adaptor were not received.The overall length of the tubing was approximately 8.5 inches left.No root cause was identified associated with the incident.All information reasonably known as of 25-jul-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 (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: CORFLO PEG KIT WITH ENFIT CONNECTOR
• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21130025
• Report Number: 2026095-2025-00002
• Device Sequence Number: 15319748
• Product Code: KNT
• UDI-Device Identifier: 00350770462233
• UDI-Public: (01)00350770462233
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K882867
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Model Number: 50-6516
• Device Catalogue Number: 50-6516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 73 YR
• Patient Sex: Male