MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 3.5 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-16-3.5-45
Medical Device Problem Codes	Complete Blockage (1094); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot aa9175n25 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Photos of the device were provided and the reported event was confirmed.However, the root cause for this incident could not be conclusively determined.All information reasonably known as of 06 aug 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.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 "medication was noted in stomach." additional information received 22-jul-2020 indicated the medication was administered via the jejunal port.Additional information received 04-aug-2020 indicated the device was in place for 21 days.There was no patient injury.The device was "changed radiologically by consultant surgeon." various medications were administered via the jejunal port.The balloon was inflated with 5ml of "cooled boiled water." information was not provided regarding the cleaning solutions or materials used in association with the product.Per information provided by the distributor, the jejunal lumen was unable to be flushed past the area of the gastric outlets.

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 3.5 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10374809
• Report Number: 9611594-2020-00142
• Device Sequence Number: 2553326
• Product Code: KNT
• UDI-Device Identifier: 00350770441016
• UDI-Public: 00350770441016
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: Lay User/Patient
• Device Expiration Date: 06/01/2021
• Device Model Number: 8270-16-3.5-45
• Device Catalogue Number: N/A
• Device Lot Number: AA9175N25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1