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

Model Number 8270-16-3.5-45

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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The product involved in the report has been returned and the investigation remains in progress at this time.Initial assessment of sample return performed on 03oct2023 identified this event to be reportable.All information reasonably known as of 23 oct 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 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.

Event Description

It was initially reported on (b)(6) 2023, the tube has split below the balloon."when completing a tube change in radiology, loss of contrast noted and leakage back towards the gut.On removal, large split noted on the tube." based on sample evaluation initiated on 03oct2023 (regulatory alert date), the evaluation confirms that the damage to the tubing allowed cross-communication between the gastric and jejunal lumens.

Manufacturer Narrative

The device history record for lot 30156416 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The sample provided was evaluated, confirming a tear located in the fourth gastric skive.The tear includes damage to the inner septum, which separates the gastric and jejunal feed lumens.However, per dhr review and process assessment conducted, there were no activities or tools identified that could cause this type of damage in the tube component.Therefore, this seems to be a user-related problem since, as per the ifu, do not use excessive force to flush the tube.Excessive force can perforate the tube.Per vygon, the device was in use for an extended period of time (100 days); which indicates that the device did not show this defect at time of placement and the tube performed as intended.The incident was confirmed as reported.The root cause is inappropriate use.All information reasonably known as of 31 oct 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 (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 (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
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 18007872
• MDR Text Key: 326566447
• Report Number: 9611594-2023-00150
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770441016
• UDI-Public: 00350770441016
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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
• Device Operator: Other
• Device Expiration Date: 09/22/2023
• Device Model Number: 8270-16-3.5-45
• Device Catalogue Number: N/A
• Device Lot Number: 30156416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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: 17 YR
• Patient Sex: Female