MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 44566

Device Problem Obstruction of Flow (2423)

Patient Problems Aspiration/Inhalation (1725); Death (1802); Dyspnea (1816); Pneumonia (2011); Sepsis (2067)

Event Date 12/24/2019

Event Type  Death  

Event Description

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 bowel obstruction,but this is a sentinel case that proves the balloon is large enough to cause obstruction.Manufacturer response for feeding tube jejunostomy, halyard (per site reporter).Will notify manufacturer once this report is submitted.

• Brand Name: HALYARD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9646707
• MDR Text Key: 176959675
• Report Number: 9646707
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 44566
• Device Catalogue Number: 8200-12LV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29565 DA