MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 18 FR, 3.5 CM; DH ENFIT MIC GJ FEEDING TUBE

Model Number 8270-18-3.5-45

Device Problem Migration (4003)

Patient Problem Vomiting (2144)

Event Date 12/12/2021

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 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 (b)(4).

Event Description

It was reported via the distributor abbvie that the patient was admitted to neurology department after vomiting.It was discovered that the jejunal end of the tube had migrated into the stomach.The patient has been receiving duodopa via a feeding tube since (b)(6) 2020.Per additional information received (b)(6) 2021, the vomiting was determined to be due to the migration of the tube into the stomach.The patient was admitted on (b)(6) 2021.The position of the tube was determined via endoscopic examination.The patient's condition is currently stable and they are awaiting placement of a new gastric-jejunal button.

Manufacturer Narrative

The device history record for lot 30090325 was reviewed and the product was produced according to product specifications.All information reasonably known as of 08 feb 2022 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 - 18 FR, 3.5 CM
• Type of Device: DH ENFIT MIC GJ FEEDING TUBE
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13077954
• MDR Text Key: 283693063
• Report Number: 9611594-2021-00191
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/09/2022
• Device Model Number: 8270-18-3.5-45
• Device Catalogue Number: N/A
• Device Lot Number: 30090325
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female