MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS GASTROSTOMY FEEDING TUBE - 16 FR; DH EF BALLOON TUBES PRODUCTS

Model Number 0112-16LV

Device Problems Material Rupture (1546); Migration (4003)

Patient Problems Abscess (1690); Fever (1858); Inflammation (1932); Pain (1994); Peritonitis (2252)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 30125518 was reviewed and the product was produced according to product specifications.The investigation remains in progress all information reasonably known as of 27 aug 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.Device not returned.

Event Description

It was reported that the patient's feeding tube retention balloon burst, which then allegedly "allowed feedings to leak into abdominal cavity." per additional information received 10 aug 2021, the patient is being followed by the infectious disease team for appropriate antibiotic therapy.The patient developed an abscess which required a procedure to drain.A new feeding tube was inserted.The patient is reported to be recovering.Per additional information received 11 aug 2021, the tube was inserted on (b)(6) 2021 and was given the ok to use order on (b)(6) 2021.Tube feeding was stopped on (b)(6) 2021, and balloon rupture was confirmed ruptured in ir (interventional radiology) on (b)(6) 2021.On (b)(6) 2021, there was copious drainage at the tube insertion site and the patient complained of pain and tenderness around the tube site.Patient's white blood cells increased from 4.1 to 12.3 and patient became febrile with temperature of 100.7.A ct scan was performed on (b)(6) 2021, which showed focal stranding (inflammation indicative of an infection) and gas in the anterior upper abdomen.Another ct scan on (b)(6) 2021 showed a 8.5cm abscess anterior to the left lobe of the liver.No further information has been provided at this time.

Event Description

It was reported via mw5103303 rec'd on 7 sep 2021, "patient came to ir for g tube evaluation ir physician scanned patient and discovered the balloon for the g tube was ruptured patient recently had g tube placed 2021 with no issues, in the interim somehow the balloon was expanded beyond recommended inflation and was ruptured unable to replace g tube due to the fresh tract of recent placement patient brought back to jr on 2021 for replacement of g tube g-tube balloon rupture that allowed tube feeds to leak into abdominal cavity.".

Manufacturer Narrative

All information reasonably known as of 23 sep 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: AVANOS GASTROSTOMY FEEDING TUBE - 16 FR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12388249
• MDR Text Key: 273328092
• Report Number: 9611594-2021-00114
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770948171
• UDI-Public: 00350770948171
• Combination Product (y/n): N
• PMA/PMN Number: K842076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: 0112-16LV
• Device Catalogue Number: N/A
• Device Lot Number: 30125518
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 77