MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC JEJUNAL FEEDING TUBE WITH ENFIT® CONNECTOR - 12 FR; DH ENFIT MIC GJ FEEDING TUBE

Model Number 8200-12LV

Device Problem Malposition of Device (2616)

Patient Problems Aspiration/Inhalation (1725); Death (1802); Pneumonia (2011); Sepsis (2067); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 12/24/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).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 (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).The device was not returned.

Event Description

It was reported the patient developed a small bowel obstruction from the balloon immediately after device placement the device was used in the standard fashion and the balloon was filled with 3ml per device use guidelines.As a result of the obstruction, the patient aspirated, developed pneumonia, and died.Upon arrival back to the hospital, the fluid in the balloon was removed, but it was too late, the aspiration had already occurred.Additional information received 08-jan-2020 stated the device balloon was retained in the patient's small intestine.The patient had a history of esophageal cancer and underwent elective jejunostomy tube placement with a 3ml filled balloon.The patient developed and immediate bowel obstruction.A computed tomography (ct) scan showed obstruction at the site of the jejunostomy tube.The patient underwent laparoscopic revision to ensure there was no twisting of the bowel (i.E.Volvulus).After that, patient had persistent low grade obstructive symptoms at home.The patient returned to the emergency room with vomiting and a productive cough.A ct scan showed persistent obstruction at the site of the balloon.The balloon was deflated.Additionally, the ct scan showed aspiration pneumonia.From the pneumonia, the patient developed sepsis and subsequently died on (b)(6) 2019 at 08:06.

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.

Manufacturer Narrative

All information reasonably known as of 06-feb-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.(b)(4).

Event Description

Additional information received 04-feb-2020 via medwatch/ fda user facility report # mw (b)(4) noted: elderly female patient with unresectable esophageal cancer and dysphagia underwent elective feeding jejunostomy tube replacement.Afterwards, she developed sbo initially thought to be related to a twist in the small bowel-this was surgically corrected.After that, her sbo failed to resolve, and repeat imaging showed that the 3ml balloon of the j-tube to be the point of obstruction.The balloon was deflated, but by that time she had already aspirated, developed pneumonia, then sepsis and death.Doctor's recommendation is to find a different j-tube that does not have a balloon.Currently the manufacturer does not offer the feeding j-tube without the balloon.It was thought that the balloon was not large enough to cause a small bowl obstruction, but this is a sentinel case that proves the balloon is large enough to cause obstruction.

• Brand Name: MIC JEJUNAL FEEDING TUBE WITH ENFIT® CONNECTOR - 12 FR
• Type of Device: DH ENFIT MIC GJ FEEDING TUBE
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9641390
• MDR Text Key: 176771602
• Report Number: 9611594-2020-00014
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651445664
• UDI-Public: 10680651445664
• 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,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8200-12LV
• Device Catalogue Number: 104456600
• Device Lot Number: UNKNOWN
• 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
• Patient Age: 81 YR
• Patient Weight: 53