| Device Type ID | 2619 |
| Device Name | Bottle, Collection, Vacuum |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KDQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2619 |
| Device | Bottle, Collection, Vacuum |
| Product Code | KDQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| CFR Regulation Number | 880.6740 [🔎] |
| Device Problems | |
|---|---|
Suction Problem | 23 |
Leak / Splash | 11 |
Material Separation | 9 |
Device Operates Differently Than Expected | 8 |
Fluid Leak | 6 |
Crack | 5 |
Break | 4 |
Burst Container Or Vessel | 4 |
Material Integrity Problem | 4 |
Connection Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Appropriate Term/Code Not Available | 3 |
Contamination During Use | 3 |
Component(s), Broken | 3 |
Collapse | 2 |
Mechanical Problem | 2 |
Shelf Life Exceeded | 2 |
Detachment Of Device Or Device Component | 2 |
Air Leak | 2 |
Unsealed Device Packaging | 2 |
Detachment Of Device Component | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Structural Problem | 2 |
Failure To Auto Stop | 2 |
Catheter | 1 |
Device Dislodged Or Dislocated | 1 |
Component Misassembled | 1 |
Occlusion Within Device | 1 |
Compatibility Problem | 1 |
Fracture | 1 |
Aspiration Issue | 1 |
Device-Device Incompatibility | 1 |
Complete Blockage | 1 |
Inadequate Or Insufficient Training | 1 |
Device Issue | 1 |
Protective Measures Problem | 1 |
Filtration Problem | 1 |
Split | 1 |
Hub | 1 |
Decrease In Suction | 1 |
Material Rupture | 1 |
Malposition Of Device | 1 |
Difficult To Advance | 1 |
| Total Device Problems | 130 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atrium Medical Corporation | II | Feb-15-2017 |
| 2 | DeRoyal Industries Inc | II | Oct-20-2014 |
| 3 | Hologic, Inc | II | Jul-19-2016 |
| 4 | Medline Industries Inc | II | Nov-03-2016 |
| 5 | Stryker Sustainability Solutions | I | Jan-04-2016 |
| 6 | Teleflex Medical | II | Apr-08-2015 |