| Device Type ID | 2530 |
| Device Name | Set, Blood Transfusion |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BRZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2530 |
| Device | Set, Blood Transfusion |
| Product Code | BRZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 147 |
Tube | 92 |
Connector | 72 |
Disconnection | 68 |
No Flow | 19 |
Filter | 17 |
Crack | 15 |
Hole In Material | 14 |
Cut In Material | 12 |
Valve | 12 |
Port | 11 |
Failure To Prime | 11 |
Device Operates Differently Than Expected | 9 |
Break | 9 |
Filling Problem | 7 |
Failure To Infuse | 7 |
Device Contamination With Chemical Or Other Material | 7 |
Connection Problem | 7 |
Air Eliminator | 7 |
Y-Piece Connector | 5 |
Fitting Problem | 5 |
Reflux Within Device | 4 |
Material Deformation | 4 |
Device Displays Incorrect Message | 4 |
Melted | 3 |
Kinked | 3 |
Material Perforation | 2 |
Improper Flow Or Infusion | 2 |
Clamp | 2 |
Complete Blockage | 2 |
Material Separation | 2 |
Material Integrity Problem | 2 |
Infusion Or Flow Problem | 2 |
Cap | 1 |
Fracture | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Component Missing | 1 |
Obstruction Of Flow | 1 |
Regulator | 1 |
Difficult To Flush | 1 |
Gas Output Problem | 1 |
Contamination / Decontamination Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Occlusion Within Device | 1 |
Device Packaging Compromised | 1 |
Unsealed Device Packaging | 1 |
Partial Blockage | 1 |
Detachment Of Device Component | 1 |
Detachment Of Device Or Device Component | 1 |
Mechanical Problem | 1 |
Material Rupture | 1 |
Failure To Disconnect | 1 |
Scratched Material | 1 |
| Total Device Problems | 605 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Genesis BPS, LLC. | II | Sep-18-2014 |