MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEED TUBE, ENFIT, 16 FR, 2.5 CM; DH EF BALLOON TUBES PRODUCTS

Model Number 8140-16-2.5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stomach Ulceration (4488)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported "a patient got a stomach ulcer.The tube was used over a month, it was placed in a patient on" (b)(6) 2024.The device reportedly had 5ml of water inside of the balloon.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 09-apr-2024 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, inc.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.H3 other text : device not returned.

• Brand Name: MIC-KEY GASTROSTOMY FEED TUBE, ENFIT, 16 FR, 2.5 CM
• 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19083773
• MDR Text Key: 339877282
• Report Number: 9611594-2024-00047
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770427485
• UDI-Public: 00350770427485
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8140-16-2.5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 39 KG