MAUDE Adverse Event Report: COVIDIEN COVIDEN SHILEY TRACHEOSTOMY PLUGS AND CAPS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 6CN75H

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Timeline: transitioned to using covidien shiley 6cn75h model, tracheostomy tube approximately around (b)(6) of 2022).On (b)(6) 2022: ent department noted issue of trach caps dislodging too easily with cough when attempted decannulation trial.To meet requirement for tracheostomy decannulation (removal of trach) at our institution, patient must be able to keep cap in place for full 24 hrs without desaturation, respiratory distress, or need for in-line suction of tracheostomy tube to clear secretions.Due to difficulty being able to facilitate capping trial (trach caps kept being coughed off which delayed discharge), we found that cap would stay in place if inner cannula was absent.This was not ideal situation but in order to be able to decannulate tracheostomy patients, we began routinely removing the inner cannula for trach decannulation.We have continued the above management since time that new tracheostomy tube model (6cn75h) was introduced potential adverse outcomes: discharge delay.Need for tracheostomy tube and supplies at discharge if unable to successfully decannulate while admitted.Mucous plug event which subsequent respiratory distress.Potential for mortality if not addressed immediately if mucous plug is significant tracheostomy; reference #: 6un75h, lot #: 22k0255jzx cap; reference #: cap lot #: 22k2032jzx.Ref report: mw5115112.

• Brand Name: COVIDEN SHILEY TRACHEOSTOMY PLUGS AND CAPS
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16434981
• MDR Text Key: 310382204
• Report Number: MW5115113
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6CN75H
• Device Catalogue Number: 6CN75H
• Device Lot Number: 22K2032JZK
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other