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 Type Of Convenience Kit, As Listed In The Guidance Above, Is
Device Type ID | 177 |
Device Name | Spinal 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 Type Of Convenience Kit, As Listed In The Guidance Above, Is |
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 Type Of Convenience Kit, As Listed In The Guidance Above, Is |
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 Type Of Convenience Kit, As Listed In The Guidance Above, Is |
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 | OFT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 177 |
Device | Spinal Epidural Anesthesia Kit |
Product Code | OFT |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Anesthesia Conduction Catheter. |
CFR Regulation Number | 868.5120 [🔎] |
Device Problems | |
---|---|
Break | 17 |
Device Damaged Prior To Use | 10 |
Material Fragmentation | 3 |
Material Separation | 2 |
Fluid Leak | 2 |
Filtration Problem | 2 |
Filter | 2 |
Catheter | 2 |
Loss Of Or Failure To Bond | 1 |
Fracture | 1 |
Output Problem | 1 |
Needle | 1 |
Material Rupture | 1 |
Device Handling Problem | 1 |
Leak / Splash | 1 |
Failure To Infuse | 1 |
Total Device Problems | 48 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Becton Dickinson & Company | II | Dec-12-2016 |