Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
| Device Type ID | 185 |
| Device Name | Epidural Anesthesia Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Regulation Description | Anesthesia Conduction 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.5120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OGE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 185 |
| Device | Epidural Anesthesia Kit |
| Product Code | OGE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Anesthesia Conduction Catheter. |
| CFR Regulation Number | 868.5120 [🔎] |
| Device Problems | |
|---|---|
Break | 72 |
Fluid Leak | 31 |
Leak / Splash | 29 |
Difficult To Position | 16 |
Failure To Infuse | 11 |
Physical Resistance | 11 |
Obstruction Of Flow | 10 |
Difficult To Advance | 10 |
Device Damaged Prior To Use | 9 |
Connection Problem | 9 |
Device Operates Differently Than Expected | 5 |
Infusion Or Flow Problem | 5 |
Device Markings / Labelling Problem | 4 |
Cut In Material | 4 |
Detachment Of Device Or Device Component | 4 |
Torn Material | 4 |
Material Fragmentation | 4 |
Material Separation | 3 |
Difficult To Remove | 3 |
Fracture | 2 |
Material Puncture / Hole | 2 |
Material Split, Cut Or Torn | 2 |
Device Dislodged Or Dislocated | 2 |
No Flow | 2 |
Hole In Material | 2 |
Partial Blockage | 2 |
Insufficient Information | 2 |
Separation Problem | 2 |
Mechanical Problem | 2 |
Kinked | 2 |
Premature Separation | 1 |
Crack | 1 |
Stretched | 1 |
Material Perforation | 1 |
Pressure Problem | 1 |
Unintended Movement | 1 |
Complete Blockage | 1 |
Catheter | 1 |
Appropriate Term/Code Not Available | 1 |
Activation, Positioning Or Separation Problem | 1 |
Difficult Or Delayed Positioning | 1 |
Contamination / Decontamination Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Uncoiled | 1 |
Burst Container Or Vessel | 1 |
Failure To Advance | 1 |
| Total Device Problems | 282 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Epimed International | II | Nov-09-2017 |