| Device Type ID | 13 |
| Device Name | Catheters, Suction, Tracheobronchial |
| Regulation Description | Tracheobronchial Suction Catheter. |
| 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) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.6810 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BSY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 13 |
| Device | Catheters, Suction, Tracheobronchial |
| Product Code | BSY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Tracheobronchial Suction Catheter. |
| CFR Regulation Number | 868.6810 [🔎] |
| Device Problems | |
|---|---|
Disconnection | 663 |
Device Operates Differently Than Expected | 142 |
Break | 53 |
Air Leak | 37 |
Nonstandard Device | 36 |
Fitting Problem | 26 |
Detachment Of Device Or Device Component | 22 |
Leak / Splash | 19 |
Loose Or Intermittent Connection | 13 |
Detachment Of Device Component | 12 |
Sticking | 11 |
Suction Problem | 10 |
Catheter | 7 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Gas Leak | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Material Fragmentation | 5 |
Crack | 5 |
Fluid Leak | 4 |
Device Dislodged Or Dislocated | 4 |
Incorrect Measurement | 4 |
Inadequate Instructions For Healthcare Professional | 3 |
Delivered As Unsterile Product | 3 |
Connection Problem | 3 |
Bent | 3 |
Inflation Problem | 3 |
Decrease In Suction | 3 |
Device Issue | 3 |
Physical Resistance / Sticking | 3 |
Partial Blockage | 2 |
Human Factors Issue | 2 |
Material Separation | 2 |
Material Rupture | 2 |
Split | 2 |
Y-Piece Connector | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Occlusion Within Device | 2 |
Cannula | 2 |
Deflation Problem | 2 |
Retraction Problem | 2 |
Use Of Device Problem | 2 |
Difficult To Open Or Close | 2 |
Component Missing | 1 |
Obstruction Of Flow | 1 |
Appropriate Term/Code Not Available | 1 |
Component Misassembled | 1 |
Extrusion | 1 |
Suction Failure | 1 |
Failure To Adhere Or Bond | 1 |
Valve | 1 |
Migration Or Expulsion Of Device | 1 |
Fracture | 1 |
Mechanical Problem | 1 |
Packaging Problem | 1 |
Noise, Audible | 1 |
Device Slipped | 1 |
Failure To Disconnect | 1 |
Malposition Of Device | 1 |
Spring | 1 |
Unsealed Device Packaging | 1 |
Device Handling Problem | 1 |
Control Switches | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
| Total Device Problems | 1163 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | I | Dec-16-2014 |
| 2 | Halyard Health | II | Feb-27-2015 |
| 3 | Halyard Health, Inc | II | Apr-18-2018 |
| 4 | Halyard Health, Inc | II | Nov-18-2017 |
| 5 | Halyard Health, Inc | II | Aug-31-2015 |
| 6 | Halyard Health, Inc | II | May-26-2015 |
| 7 | Medline Industries Inc | II | Nov-18-2017 |
| 8 | Vyaire Medical | I | Aug-21-2018 |