| Device Type ID | 11 |
| Device Name | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Regulation Description | Anesthesia Conduction Needle. |
| 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 | 868.5150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BSP |
| 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 | 11 |
| Device | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Product Code | BSP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Anesthesia Conduction Needle. |
| CFR Regulation Number | 868.5150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAJUNK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
PAJUNK GMBH MEDIZINTECHNOLOGIE | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
REMINGTON MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITHS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SMITHS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPECTRA MEDICAL DEVICES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SUMMIT MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNISIS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Nonstandard Device | 36 |
Product Quality Problem | 36 |
No Flow | 36 |
Fracture | 35 |
Fluid Leak | 34 |
Manufacturing, Packaging Or Shipping Problem | 34 |
Break | 33 |
Crack | 21 |
Device Handling Problem | 20 |
Patient-Device Incompatibility | 11 |
Failure To Adhere Or Bond | 10 |
Device Issue | 9 |
Mechanical Jam | 9 |
Inadequacy Of Device Shape And/or Size | 8 |
Incorrect Device Or Component Shipped | 8 |
Device Misassembled During Manufacturing / Shipping | 7 |
Improper Or Incorrect Procedure Or Method | 7 |
Bent | 4 |
Insufficient Information | 4 |
Device Markings / Labelling Problem | 4 |
Detachment Of Device Component | 3 |
Leak / Splash | 3 |
Human Factors Issue | 3 |
Material Fragmentation | 3 |
Difficult To Remove | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Physical Property Issue | 2 |
Loss Of Or Failure To Bond | 2 |
Needle | 2 |
Flushing Problem | 2 |
Blocked Connection | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Flow Or Under Infusion | 1 |
Hole In Material | 1 |
Excess Flow Or Over-Infusion | 1 |
Material Separation | 1 |
Pumping Problem | 1 |
Misassembly By Users | 1 |
Tube | 1 |
Device-Device Incompatibility | 1 |
Sticking | 1 |
Failure To Infuse | 1 |
Device Contamination With Biological Material | 1 |
Accessory Incompatible | 1 |
Device Dislodged Or Dislocated | 1 |
Material Split, Cut Or Torn | 1 |
Cannula | 1 |
Physical Resistance | 1 |
Infusion Or Flow Problem | 1 |
Material Twisted / Bent | 1 |
Device Contamination With Body Fluid | 1 |
Compatibility Problem | 1 |
Contamination During Use | 1 |
| Total Device Problems | 415 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | B. Braun Medical, Inc. | II | May-28-2014 |
| 2 | Epimed International, Inc. | II | Oct-31-2016 |
| 3 | Integra LifeSciences Corp. D.b.a. Integra Pain Management | II | Jul-09-2015 |
| 4 | Integra LifeSciences Corp. D.b.a. Integra Pain Management | II | Apr-29-2015 |
| 5 | RM Temena GmbH | II | May-12-2014 |