MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 12 FR, 0.8 CM; DH EF BALLOON TUBES PRODUCTS

Model Number 0120-12-0.8

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Irritation (2076)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record for the reported lot number, aa8330f63, 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.All information reasonably known as of 08-jan-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 the enteral feeding tube balloon began leaking after 2-days of being in place, causing skin breakdown at the stoma site.The skin breakdown was due to gastric secretions.The patient had to be placed on oral and topical antibiotics, bactroban ointment.At the time of this report the patient's skin had healed.

Manufacturer Narrative

Correction d4 one used sample was received along with the product packaging label.The device was evaluated and the failure was not confirmed.A root cause was not identified.All information reasonably known as of (b)(6)2020 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.

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 12 FR, 0.8 CM
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9568490
• MDR Text Key: 196086075
• Report Number: 9611594-2020-00005
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770948270
• UDI-Public: 00350770948270
• Combination Product (y/n): N
• PMA/PMN Number: K043114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2020
• Device Model Number: 0120-12-0.8
• Device Catalogue Number: 109482701
• Device Lot Number: AA8330F63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2020
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 18