MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC J FEEDING TUBE - 20 FR; DH EF BALLOON TUBES PRODUCTS

Model Number 0200-20

Device Problems Deflation Problem (1149); Malposition of Device (2616)

Patient Problems Death (1802); Necrosis (1971); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 10/28/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The device history record for the reported lot number, aa9028n05, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.All information reasonably known as of (b)(6) 2020 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.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).(b)(4).The device was not returned.

Event Description

It was reported via medwatch/ fda user facility report # (b)(4): patient had j tube placement.Flush of d5 30cc q 6 hours to follow.Patient with acute respiratory distress and failure due to aspiration pneumonia and transfer to the ticu 2 days later.On ct was found to have sbo at site of j tube insertion.With rising lactic acid and worsening status, patient went to or 2 days later.Found to have balloon dilated greater than 100cc causing bowel necrosis of surrounding area.Unable to aspirated fluid through during the or" (sbo=small bowel obstruction).Or findings j-tube balloon was thought to be fully deflated two days prior to the or however intraoperatively the balloon was found to be hyperinflated and tense (size of a large lemon) obstructing the lumen and stretching bowel well, causing contusion on one side of the bowel along the line of maximum tension.The balloon port was nonfunctional (unable to aspirate the fluid out using during per usual fashion) and the side port was cut using mayo scissors to release the fluid from the balloon (~ 100cc).Old j-tube then removed (20fr (0200-20) lot aa9028n05) and a new one replaced.What was the original intended procedure? medication flush.The event occurred in (b)(6) 2019.Additional information indicates the patient is deceased.The specific cause of death was not noted.An autopsy was not performed, however it does not appear to be related to the reported incident.

Manufacturer Narrative

Additional information: b3.All information reasonably known as of 08-may-2020 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.

• Brand Name: MIC J FEEDING TUBE - 20 FR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9792301
• MDR Text Key: 182135851
• Report Number: 9611594-2020-00040
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651949759
• UDI-Public: 10680651949759
• Combination Product (y/n): N
• PMA/PMN Number: K853197
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 0200-20
• Device Catalogue Number: 109497501
• Device Lot Number: AA9028N05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 68 YR