| Device Type ID | 21 |
| Device Name | Tube, Tracheostomy (w/wo Connector) |
| Regulation Description | Tracheostomy Tube And Tube Cuff. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BTO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 21 |
| Device | Tube, Tracheostomy (w/wo Connector) |
| Product Code | BTO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheostomy Tube And Tube Cuff. |
| CFR Regulation Number | 868.5800 [🔎] |
| Device Problems | |
|---|---|
Cuff | 294 |
Air Leak | 236 |
Leak / Splash | 111 |
Tube | 63 |
Fracture | 48 |
Inflation Problem | 43 |
Break | 36 |
Crack | 27 |
Cannula, Inner | 27 |
Flange | 25 |
Detachment Of Device Component | 20 |
Decrease In Pressure | 18 |
Eyelet | 16 |
Human-Device Interface Problem | 16 |
Material Integrity Problem | 14 |
Balloon | 14 |
Cannula | 13 |
Connector | 11 |
Material Rupture | 10 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Deflation Problem | 10 |
Device Operates Differently Than Expected | 10 |
Connection Problem | 9 |
Torn Material | 9 |
Inadequacy Of Device Shape And/or Size | 8 |
Pilot Balloon Valve | 7 |
Hole In Material | 7 |
Noise, Audible | 7 |
Suction Problem | 7 |
Fluid Leak | 6 |
Component(s), Broken | 6 |
Material Perforation | 6 |
Split | 6 |
Device Damaged Prior To Use | 6 |
Device Alarm System | 6 |
Unintended Movement | 6 |
Sticking | 5 |
System | 5 |
Detachment Of Device Or Device Component | 5 |
Gas Leak | 5 |
Patient-Device Incompatibility | 4 |
Device Dislodged Or Dislocated | 4 |
Catheter | 4 |
Occlusion Within Device | 4 |
Manufacturing, Packaging Or Shipping Problem | 4 |
Contamination Of Device Ingredient Or Reagent | 4 |
Material Deformation | 3 |
Fitting Problem | 3 |
Locking Mechanism | 3 |
Inaccurate Information | 3 |
Positioning Problem | 3 |
Failure To Disconnect | 3 |
Kinked | 3 |
Loose Or Intermittent Connection | 3 |
Cut In Material | 3 |
Misassembled | 3 |
Material Split, Cut Or Torn | 3 |
Component Missing | 3 |
Obstruction Of Flow | 3 |
Seal | 3 |
Burst Container Or Vessel | 3 |
Difficult To Remove | 3 |
Infusion Or Flow Problem | 3 |
Device Component Or Accessory | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Defective Component | 3 |
Guidewire | 2 |
Valve | 2 |
Safety Interlock(s) Inadequate | 2 |
Physical Resistance | 2 |
Bent | 2 |
Use Of Device Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Label | 2 |
Shaft | 2 |
Heat Exchanger | 2 |
Device Slipped | 2 |
Defective Device | 2 |
Mechanical Problem | 2 |
Disconnection | 2 |
Difficult To Insert | 2 |
Hub | 2 |
Malposition Of Device | 2 |
Difficult To Advance | 2 |
Material Fragmentation | 2 |
Component Or Accessory Incompatibility | 2 |
Partial Blockage | 2 |
Pressure Problem | 2 |
Physical Resistance / Sticking | 2 |
Peeled / Delaminated | 1 |
Coil | 1 |
Accessory Incompatible | 1 |
Human Factors Issue | 1 |
Material Separation | 1 |
Device Handling Problem | 1 |
Brush | 1 |
Ring | 1 |
Component Incompatible | 1 |
Scratched Material | 1 |
Premature Separation | 1 |
| Total Device Problems | 1329 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ambu Inc. | II | Mar-24-2016 |
| 2 | Instrumentation Industries Inc | II | Nov-12-2015 |
| 3 | Smiths Medical ASD Inc. | II | Jun-07-2018 |