MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN SHILEY TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 6CN75H

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problems Ventilator Dependent (2395); Low Oxygen Saturation (2477); Unspecified Heart Problem (4454)

Event Date 12/01/2022

Event Type  Injury  

Event Description

I have a shiley trach tube and on a ventilator with oxygen.The last trach tube leaked air badly around the trach when inflated to the max the doctor prescribed (30cm of pressure using a medical grade manometer).Due to the leakage, i was unable to get the oxygenation required and other medical problem (heart, etc) as a result.Note that the max pressure was reached at just 5cc of air.That tube was replaced yesterday and the new trach tube, of the same model, hits the 30cm of pressure at 8cc.More importantly, there is no leakage around the trach tube so apparently, the previous cuff was too stiff and hit the max pressure before it was large enough to block the airway.In other words, terrible quality control.

• Brand Name: SHILEY TRACH TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 16052459
• MDR Text Key: 306281806
• Report Number: MW5114023
• 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: Patient
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6CN75H
• Device Catalogue Number: 6CN75H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White