| Device Type ID | 2582 |
| Device Name | Tubing, Fluid Delivery |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FPK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2582 |
| Device | Tubing, Fluid Delivery |
| Product Code | FPK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 8 |
Adapter (Adaptor) | 6 |
Occlusion Within Device | 6 |
Break | 5 |
Disconnection | 5 |
Insufficient Flow Or Under Infusion | 4 |
Detachment Of Device Component | 3 |
Leak / Splash | 3 |
Tube | 3 |
No Apparent Adverse Event | 3 |
Valve | 2 |
Y-Piece Connector | 2 |
Material Disintegration | 2 |
Material Separation | 2 |
Loose Or Intermittent Connection | 2 |
Crack | 2 |
Split | 2 |
Insufficient Information | 2 |
Inaccurate Delivery | 1 |
Sticking | 1 |
One-Way Valve | 1 |
Disassembly | 1 |
Difficult To Flush | 1 |
Failure To Deliver | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Dial | 1 |
| Total Device Problems | 70 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hospira Inc. | II | Jan-11-2017 |
| 2 | Medtronic Inc. | II | Nov-18-2017 |