MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD* MIC* JEJUNOSTOMY FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Vomiting (2144)

Event Date 11/16/2019

Event Type  malfunction  

Event Description

Patient admitted with existing 6fr ng tube in place.Rn describes the kangaroo pump "continuously alarming back flow".Rn disconnected the feeds from the patient and flushed tubing with 5 ml syringe using pulsatile flush.It was initially sluggish followed by free flow.Feeds restarted.Approximately 5 minutes later the secretions from ett changed consistency and looked like potential feeds.Approximately two weeks later , feeds were paused, md notified.Doctor assessed and decided it was not feeds.Feeds restarted.X-ray called per rn request the next day, tip in correct position.Next day, emesis of undigested feeds pooling in mouth.Feeds stopped for remainder of the night.In reviewing x-ray in morning the tube was found to be completely split in two pieces within patient.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9805174
• MDR Text Key: 182556511
• Report Number: 9805174
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA