MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 24 FR, 3.0 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-24-3.0
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Irritation (2076)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record is in-progress.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 23 nov 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 or Problem Description
It was reported that the feeding tube was placed at home with 6mls water on (b)(6) 2020.The device came out of the stoma on (b)(6) 2020.The device was replaced, and it was reported that the skin around the stoma site was "burned." additional information indicated that the area was cleaned with, "weak saline and applied silbicore." a stoma paste was also applied around the stoma to support any further leakage.Patient's current condition is "stable.".
Additional Manufacturer Narrative
The device history record for lot 20020421 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.One used sample was received without product packaging.The reported event was confirmed; however, a root cause could not be conclusively determined.All information reasonably known as of 15 jan 2021 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 - 24 FR, 3.0 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10897145
• Report Number: 9611594-2020-00236
• Device Sequence Number: 3253843
• Product Code: KNT
• UDI-Device Identifier: 00350770949192
• UDI-Public: 00350770949192
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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 Expiration Date: 12/01/2021
• Device Model Number: 0120-24-3.0
• Device Catalogue Number: N/A
• Device Lot Number: 20020421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 60