| Device Type ID | 2630 |
| Device Name | Container, I.v. |
| Regulation Description | I.V. Container. |
| 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 | 880.5025 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KPE |
| 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 | 2630 |
| Device | Container, I.v. |
| Product Code | KPE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | I.V. Container. |
| CFR Regulation Number | 880.5025 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
VALMED SRL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 591 |
Device Contamination With Chemical Or Other Material | 425 |
Bags | 162 |
Port | 105 |
Hole In Material | 73 |
Seal | 40 |
Disconnection | 35 |
Break | 29 |
Leak / Splash | 21 |
Contamination / Decontamination Problem | 16 |
Tube | 15 |
Cut In Material | 15 |
Particulates | 10 |
Cap | 7 |
Detachment Of Device Or Device Component | 6 |
Crack | 6 |
Failure To Disconnect | 6 |
Material Rupture | 5 |
Material Deformation | 5 |
Loose Or Intermittent Connection | 4 |
Hermetic Seal | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Degraded | 3 |
Connection Problem | 3 |
Connector | 3 |
Improper Chemical Reaction | 2 |
Device Damaged Prior To Use | 2 |
Material Perforation | 2 |
Microbial Contamination Of Device | 2 |
No Flow | 2 |
Material Integrity Problem | 2 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Contamination During Use | 1 |
Misconnection | 1 |
Product Quality Problem | 1 |
Burst Container Or Vessel | 1 |
Failure To Prime | 1 |
Problem With Sterilization | 1 |
Material Split, Cut Or Torn | 1 |
Component Missing | 1 |
Reservoir | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Misassembled | 1 |
Membrane | 1 |
Detachment Of Device Component | 1 |
Fitting Problem | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Clamp | 1 |
Material Separation | 1 |
| Total Device Problems | 1624 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp | I | Oct-31-2014 |
| 2 | Baxter Healthcare Corporation | II | Nov-02-2018 |
| 3 | Baxter Healthcare Corporation | II | Jan-11-2018 |
| 4 | The Metrix Company | II | Sep-29-2017 |