MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 18 FR, 1.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-18-1.7-30
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 02 feb 2021 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 initially reported that the device was changed due to leaking.The device was returned and on (b)(6) 2021 it was identified that the inner wall of the tubing which separates the jejunal and gastric lumens had torn, allowing for inner lumen crossover.Additional information received 21-jan-2021 indicated there was no patient harm.No further details were available.
Additional Manufacturer Narrative
The device history record for lot 30044673 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.Sample evaluation confirmed build-ups inside the lumen that cannot be flushed due to the condition of the lumens being torn; the obstructions are usually caused by formula/feed accumulation inside the tube.No manufacturing related issues were identified during the investigation.Root cause could not be determined.All information reasonably known as of 04 mar 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 GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 18 FR, 1.7 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11276010
• Report Number: 9611594-2021-00016
• Device Sequence Number: 3720961
• Product Code: KNT
• UDI-Device Identifier: 00350770441092
• UDI-Public: 00350770441092
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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 Expiration Date: 03/01/2022
• Device Model Number: 8270-18-1.7-30
• Device Catalogue Number: N/A
• Device Lot Number: 30044673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1