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

Model Number 50-6012E1

Device Problem Difficult to Advance (2920)

Patient Problems Swelling (2091); Skin Inflammation (2443)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 02 oct 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

Event Description

It was reported that the patient's caregiver found it difficult to advance the peg tube the last two times opening the fixator plate.After a couple of hours, it was noticed the stoma site was red, and swollen.Patient was brought to the emergency department, and commenced on antibiotics.Additional information received 14-sep-2020 indicated that the patient's current condition, and whether any other medical interventions were required are unknown.

• Brand Name: CORFLO PEG KIT WITH ENFIT CONNECTOR
• Type of Device: DH CPK 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 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10631261
• MDR Text Key: 210712393
• Report Number: 3006646024-2020-00033
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10815149021741
• UDI-Public: 10815149021741
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K882867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 50-6012E1
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other