MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 93826

Device Problems Device Alarm System (1012); Break (1069); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

Patient was having his diaper changed with 2 rns.All of the sudden, heard air leaking and then vent alarming.Upon inspection, end of endotracheal tube (ett) where it connects to the ballard suction actually broke off, rns pushed staff assist, team at bedside instructed to pull ett and bag, team reintubating patient.Suction adapter that inserts into et tube broke off after a patient move.The tip of the adapter was wedged inside of the et tube which did not allow for any manual or mechanical ventilation connectivity.Decision was made to pull et tube and reintubate.No patient harm after reintubation.

• Brand Name: AVANOS
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16814865
• MDR Text Key: 314023181
• Report Number: 16814865
• Device Sequence Number: 1
• Product Code: BSY
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 93826
• Device Catalogue Number: 198
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2023
• Date Report to Manufacturer: 04/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Sex: Male