MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 2.3 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-16-2.3-30
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot aa9056n20 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The investigation remains in progress.All information reasonably known as of 26 jan 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 valve on the gastric port of the gj [gastro-jejunal] tube was broken resulting in leaking from the valve, requiring the tube to be replaced.Tube was inserted on (b)(6) 2020 and patient was at home at time of breakage on (b)(6) 2020.Patient attended medical imaging on (b)(6) 2020 for tube change.Additional information received 18-jan-2021 indicated the returned sample exhibited a tear in the inner septum of the tubing which separates the jejunal and gastric lumens, allowing for cross-lumen communication.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.The jejunal and gastric lumens had a tear which allowed for cross-lumen communication.A definitive root cause could not be determined.Per the product's instructions for use, excessive force can perforate the tube and can cause injury to the gastrointestinal tract.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 - 16 FR, 2.3 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11237539
• Report Number: 9611594-2021-00013
• Device Sequence Number: 3842967
• Product Code: KNT
• UDI-Device Identifier: 00350770440941
• UDI-Public: 00350770440941
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• 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: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: 8270-16-2.3-30
• Device Catalogue Number: N/A
• Device Lot Number: AA9056N20
• 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: 01/18/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/27/2021
• 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