MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 2.7 CM - 30 - NON-ENFIT; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-16-2.7-30
Medical Device Problem Codes	Complete Blockage (1094); 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 actual complaint product was not returned for evaluation.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).
Event or Problem Description
It was reported, "the issue appears to be a blockage and subsequent rupture of the jejunal lumen just distal to the balloon at approximately the same location as the gastric exit points." the device was in use for one month.There was no reported injury.
Additional Manufacturer Narrative
The device history record for the reported lot number, aa9161n23, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 03-sep-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 GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 2.7 CM - 30 - NON-ENFIT
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10254999
• Report Number: 9611594-2020-00115
• Device Sequence Number: 2678899
• Product Code: KNT
• UDI-Device Identifier: 00350770956466
• UDI-Public: 00350770956466
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: 06/01/2021
• Device Model Number: 0270-16-2.7-30
• Device Catalogue Number: N/A
• Device Lot Number: AA9161N23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1