| Device Type ID | 25 |
| Device Name | Tube, Bronchial (w/wo Connector) |
| Regulation Description | Bronchial Tube. |
| 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 | 868.5720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BTS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 25 |
| Device | Tube, Bronchial (w/wo Connector) |
| Product Code | BTS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bronchial Tube. |
| CFR Regulation Number | 868.5720 [🔎] |
| Device Problems | |
|---|---|
Deflation Problem | 203 |
Inflation Problem | 74 |
Leak / Splash | 65 |
Break | 45 |
Cuff | 35 |
Gas Leak | 30 |
Detachment Of Device Component | 21 |
Human-Device Interface Problem | 17 |
Connection Problem | 15 |
Partial Blockage | 14 |
Air Leak | 14 |
Crack | 14 |
Detachment Of Device Or Device Component | 13 |
Disconnection | 13 |
Device Operates Differently Than Expected | 10 |
Material Integrity Problem | 9 |
Device Damaged Prior To Use | 9 |
Material Separation | 5 |
Tube | 5 |
Bent | 5 |
Burst Container Or Vessel | 4 |
Contamination During Use | 4 |
Material Deformation | 4 |
Loose Or Intermittent Connection | 4 |
Difficult To Advance | 4 |
Pressure Problem | 3 |
Fitting Problem | 3 |
Balloon | 3 |
Component Missing | 3 |
Obstruction Of Flow | 3 |
Activation, Positioning Or Separation Problem | 2 |
Material Puncture / Hole | 2 |
Optical Obstruction | 2 |
Occlusion Within Device | 2 |
Product Quality Problem | 2 |
Contamination Of Device Ingredient Or Reagent | 2 |
Sticking | 2 |
Hole In Material | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Device Markings / Labelling Problem | 2 |
Kinked | 2 |
Insufficient Information | 2 |
Split | 2 |
Overheating Of Device | 1 |
Connector | 1 |
Difficult To Insert | 1 |
Material Rupture | 1 |
Positioning Problem | 1 |
Device Issue | 1 |
Folded | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Peeled / Delaminated | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Device Operational Issue | 1 |
Chemical Problem | 1 |
Ventilation Problem In Device Environment | 1 |
Loss Of Or Failure To Bond | 1 |
Device Dislodged Or Dislocated | 1 |
Catheter | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
| Total Device Problems | 696 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | II | Mar-19-2014 |
| 2 | Teleflex, Inc. | II | Aug-18-2015 |