| Device Type ID | 10 |
| Device Name | Catheter, Conduction, Anesthetic |
| 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 | 510(k) |
| CFR Regulation Number | 868.5120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BSO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 10 |
| Device | Catheter, Conduction, Anesthetic |
| Product Code | BSO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Anesthesia Conduction Catheter. |
| CFR Regulation Number | 868.5120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EPIMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EPIMED INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HALYARD HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMEDICOM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KIMBERLY-CLARK CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KIMBERLY-CLARK CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PAJUNK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PAJUNK GMBH MEDIZINTECHNOLOGIE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL , INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 161 |
Device Handling Problem | 26 |
Adverse Event Without Identified Device Or Use Problem | 22 |
Device Operates Differently Than Expected | 20 |
Device Damaged By Another Device | 14 |
Human Factors Issue | 12 |
Split | 12 |
Catheter | 12 |
Torn Material | 10 |
Physical Resistance / Sticking | 9 |
Improper Or Incorrect Procedure Or Method | 9 |
Retraction Problem | 8 |
Use Of Device Problem | 8 |
Device Issue | 8 |
Difficult To Advance | 7 |
Fracture | 7 |
Difficult To Remove | 7 |
Obstruction Of Flow | 5 |
Entrapment Of Device | 5 |
Positioning Problem | 5 |
Premature Separation | 4 |
Detachment Of Device Or Device Component | 4 |
Mechanical Problem | 4 |
Stretched | 4 |
No Flow | 4 |
Failure To Adhere Or Bond | 4 |
Inaccurate Flow Rate | 3 |
Fluid Leak | 3 |
Labelling, Instructions For Use Or Training Problem | 3 |
Material Fragmentation | 3 |
Material Separation | 2 |
Patient Device Interaction Problem | 2 |
Device-Device Incompatibility | 2 |
Leak / Splash | 2 |
Difficult To Position | 2 |
Device Or Device Fragments Location Unknown | 2 |
Product Quality Problem | 2 |
Tip Breakage | 2 |
Device, Or Device Fragments Remain In Patient | 2 |
Material Twisted / Bent | 2 |
Patient-Device Incompatibility | 2 |
Connection Problem | 2 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
Device Dislodged Or Dislocated | 1 |
Component Missing | 1 |
Uncoiled | 1 |
Physical Resistance | 1 |
Device Inoperable | 1 |
Contamination During Use | 1 |
Defective Device | 1 |
Filter | 1 |
Cut In Material | 1 |
Nonstandard Device | 1 |
Cross Reactivity | 1 |
Loose Or Intermittent Connection | 1 |
Material Rupture | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Sticking | 1 |
Failure To Infuse | 1 |
Mechanical Jam | 1 |
| Total Device Problems | 446 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | B. Braun Medical, Inc. | II | Oct-01-2018 |