| Device Type ID | 471 |
| Device Name | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Regulation Description | Blood Specimen Collection Device. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1675 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JKA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 471 |
| Device | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Product Code | JKA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Specimen Collection Device. |
| CFR Regulation Number | 862.1675 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIO-ANALYSIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GREINER BIO-ONE NA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PATHWAY LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOL-MILLENNIUM MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VELANO VASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 2216 |
Leak / Splash | 1936 |
Device Contamination With Chemical Or Other Material | 1488 |
Short Fill | 1301 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 926 |
Volume Accuracy Problem | 864 |
Overfill | 527 |
Coagulation In Device Or Device Ingredient | 452 |
Material Deformation | 444 |
Device Markings / Labelling Problem | 409 |
Product Quality Problem | 132 |
Break | 125 |
Material Protrusion / Extrusion | 110 |
Delivered As Unsterile Product | 109 |
Difficult To Insert | 100 |
Component Missing | 86 |
Difficult Or Delayed Activation | 73 |
Incorrect Measurement | 61 |
Complete Blockage | 58 |
No Device Output | 46 |
Fluid Leak | 28 |
Fracture | 26 |
Packaging Problem | 24 |
Needle | 18 |
Device Damaged Prior To Use | 18 |
Manufacturing, Packaging Or Shipping Problem | 15 |
Improper Or Incorrect Procedure Or Method | 15 |
Syringe | 15 |
Shipping Damage Or Problem | 11 |
Luer Valve | 10 |
Component Incompatible | 10 |
Detachment Of Device Component | 10 |
Device Contamination With Body Fluid | 9 |
Appropriate Term/Code Not Available | 8 |
Device Difficult To Setup Or Prepare | 7 |
Corroded | 7 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Device Operates Differently Than Expected | 5 |
Device Damaged By Another Device | 5 |
Fungus In Device Environment | 5 |
Crack | 4 |
Fail-Safe Design Failure | 4 |
Device Handling Problem | 3 |
Mechanical Problem | 3 |
Insufficient Information | 3 |
Loose Or Intermittent Connection | 3 |
Device Operational Issue | 3 |
Retraction Problem | 3 |
Cap | 2 |
Failure To Prime | 2 |
Material Twisted / Bent | 2 |
Device Disinfection Or Sterilization Issue | 2 |
Improper Chemical Reaction | 2 |
Device Slipped | 2 |
Defective Device | 2 |
Labelling, Instructions For Use Or Training Problem | 2 |
Adapter (Adaptor) | 2 |
Protective Measures Problem | 2 |
Expulsion | 1 |
Material Fragmentation | 1 |
Hole In Material | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Inadequate Or Insufficient Training | 1 |
Separation Failure | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Filter | 1 |
Detachment Of Device Or Device Component | 1 |
Microbial Contamination Of Device | 1 |
Device Component Or Accessory | 1 |
Difficult To Remove | 1 |
Inaccurate Synchronization | 1 |
Bent | 1 |
Gas Leak | 1 |
Lock | 1 |
Contamination During Use | 1 |
Device Ingredient Or Reagent Problem | 1 |
Compatibility Problem | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Failure To Deliver | 1 |
Tip | 1 |
Duplexer | 1 |
High Test Results | 1 |
Chemical Problem | 1 |
| Total Device Problems | 11789 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Company | II | Jun-20-2018 |
| 2 | Becton Dickinson & Company | II | Jun-01-2018 |
| 3 | Becton Dickinson & Company | II | Apr-26-2018 |
| 4 | Becton Dickinson & Company | II | Mar-26-2018 |
| 5 | Becton Dickinson & Company | I | Mar-22-2018 |
| 6 | Becton Dickinson & Company | II | Mar-12-2018 |
| 7 | Becton Dickinson & Company | II | Nov-09-2017 |
| 8 | Becton Dickinson & Company | II | Apr-06-2017 |
| 9 | Becton Dickinson & Company | II | Feb-10-2017 |
| 10 | Becton Dickinson & Company | II | Dec-12-2016 |
| 11 | Becton Dickinson & Company | II | Sep-01-2016 |
| 12 | Becton Dickinson & Company | II | Dec-31-2015 |
| 13 | Becton Dickinson & Company | II | Dec-21-2015 |
| 14 | Becton Dickinson & Company | III | Aug-20-2015 |
| 15 | Becton Dickinson & Company | II | Jun-26-2015 |
| 16 | Fresenius Medical Care Holdings, Inc. | II | Sep-12-2014 |
| 17 | Greiner Bio-One North America, Inc. | II | Jun-07-2016 |
| 18 | Siemens Healthcare Diagnostics Inc | II | Mar-06-2015 |
| 19 | Smiths Medical ASD Inc. | II | Feb-15-2019 |
| 20 | Smiths Medical ASD Inc. | III | Sep-19-2018 |
| 21 | Smiths Medical ASD, Inc. | III | Jan-29-2015 |
| 22 | Smiths Medical ASD, Inc. | II | Mar-12-2014 |