MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 1.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number 8270-16-1.7-30

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)

Patient Problem Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned for evaluation.The investigation is in process at this time.A review of the device history record is in-progress.All information reasonably known as of 06 may 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that the patient returned to the hospital two and a half weeks after replacement of the tube due to vomiting which occurred when the jejunal connector was being used for feeding.The balloon was deflated and the feeding tube was inspected.A perforation of the tubing was found just below the balloon, in the area between the stomach and the duodenum, resulting in a possible leak into the stomach of feed intended for the jejunum.A new feeding tube was placed.Per additional information received 19 apr 2021, after the changing out of the feeding tube, "everything is ok.".

Manufacturer Narrative

One sample was returned for evaluation.Examination revealed visible tearing of the first gastric skive and of the inner septum in that area.Testing the tube using colored water revealed a leak at the gastric skive area.The complaint is confirmed, however, no root cause could be determined.The device history record for lot 30021302 was reviewed and the product was produced according to product specifications.All information reasonably known as of 09 jun 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 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, 1.7 CM
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11790810
• MDR Text Key: 252406648
• Report Number: 9611594-2021-00068
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770440897
• UDI-Public: 00350770440897
• Combination Product (y/n): N
• PMA/PMN Number: K922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Model Number: 8270-16-1.7-30
• Device Catalogue Number: N/A
• Device Lot Number: 30021302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 25