MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT (ENFIT); DH EF BALLOON TUBES PRODUCTS

Model Number 8270-18-2.0-30

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

H6: investigation findings: appropriate term/code not available: malfunction observed without conclusive finding the device history record for lot 30228950 was reviewed and the product was produced according to product specifications.The sample was returned for evaluation which determined this event to be reportable on regulatory alert date (b)(6) 2023.After cleaning and decontamination, the sample was examined in a well lit area.It appears in generally clean condition.The molded head, tube and balloon do not exhibit discoloration or buildup.The tubing was then examined under magnification.A cur or tear was observed in the gastric skives.The tear includes damage to the inner septum which separates the gastric and jejunal feed lumens.Feeding was then simulated using water mixed with food grade dye.Simulated feeding through the gastric port exhibited the water exiting the area of gastric skives.When feeding through the jejunal port, the water exited the damaged gastric skives.The incident was confirmed as reported.A root cause could not be determined.All information reasonably known as of (b)(6) 2023 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint comp(b)(4).This information is submitted pursuant to (b)(4), 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.

Event Description

It was reported, ¿there was a leak from the tube.Not sure which it came from gastric line or jejunal line.¿ no injury or medical interventions reported.

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT (ENFIT)
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 18005446
• MDR Text Key: 326519885
• Report Number: 9611594-2023-00151
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770441139
• UDI-Public: 00350770441139
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8270-18-2.0-30
• Device Catalogue Number: N/A
• Device Lot Number: 30228950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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