MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 FR,; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-14-1.5
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Local Reaction (2035); Swelling (2091)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 16 dec 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported by the patient's parent that two days after replacement of the device on (b)(6) 2020, the stoma site became red and swollen, and iv antibiotics were prescribed.The site improved, however, today, (b)(6) 2020, the parent reports that the site has swollen up again.The patient has had a feeding tube for two years, with four tube changes in that time.The patient did not have any reactions prior to this.Per additional information provided by the patient's parent on 7 dec 2020, the device is the correct size and the first reaction began on (b)(6) 2020.The patient is still experiencing issues with the stoma site.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 FR,
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11021726
• Report Number: 9611594-2020-00243
• Device Sequence Number: 3594163
• Product Code: KNT
• UDI-Device Identifier: 00350770427270
• UDI-Public: 00350770427270
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 8140-14-1.5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• 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: 11/28/2020
• Initial Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR