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

Model Number	50-6016E1
Medical Device Problem Codes	Difficult to Remove (1528); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 30289162, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and is being processed for evaluation.A review of the udi number is in-progress.All information reasonably known as of 07-nov-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.
Event or Problem Description
It was reported via mhra: (b)(4) the following information: "there was an incident where the wire split through the tube at the end of the [percutaneous endoscopic gastrostomy] peg.Corflo peg inserted on (b)(6) 2024.Initially a straightforward insertion, however wire split through the tube at the end of the peg, making it difficult to pull through the stomach.This caused trauma for the patient as the wire is not meant to split through the plastic.[office of generic drugs] ogd showed peg bumper appropriately positioned.Use of peg was held for 24 hours to allow abdomen to settle.Peg tip was cut and sent to medical physics with analysis.Patient monitored closely post peg and has remained stable." additional information received stated, "patient was not injured however there was a number of problems post insertion, such as the peg was not functioning and it was impossible to flush the tube.He needed a [computed tomography] ct scan and a tubogram.There was something within the tube stopping it from being flushed and this was pushed through with a soft wire 4-days after insertion.It was not possible to retrieve this as it was done in interventional radiology.The patient was unable to be fed for 5-days.".
Additional Manufacturer Narrative
Additional information: d4.The sample received was evaluated.The bag the sample was received had the peel-away sticker from the product packaging.After cleaning and decontamination, the sample was examined in a well-lit area.The returned sample consisted of a length of tubing measuring approximately 5.8cm in length.There was what appeared to be a segment of guidewire inside the tubing.The sample was examined under magnification.At one end, the tubing exhibited a jagged axial tear.There were two ends of the guidewire protruding from this tear.The length of tubing appeared somewhat tapered at the torn end.During the sample evaluation, it was observed that at one end, the tubing exhibited a jagged axial tear.Two ends of the guidewire protruded from that tear.Root cause could not be determined.All information reasonably known as of 04-sep-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: 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: 20634398
• Report Number: 2026095-2024-00063
• Device Sequence Number: 7369649
• Product Code: KNT
• UDI-Device Identifier: 10350770462070
• UDI-Public: (01)10350770462070(240)120004981(11)231106(17)261105(10)30289162
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 50-6016E1
• Device Catalogue Number: 50-6016E1
• Device Lot Number: 30289162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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: 20 YR
• Patient Sex: Male
• Patient Weight: 65 KG