| Device Type ID | 2655 |
| Device Name | Set, I.v. Fluid Transfer |
| 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 | LHI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2655 |
| Device | Set, I.v. Fluid Transfer |
| Product Code | LHI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BAXTER HEALTHCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAXTER HEALTHCARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DUOJECT MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOSPIRA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LABORATORIOS GRIFOLS, S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIMOP MEDICAL PROJECTS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDSOURCE INTERNATIONAL, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PFIZER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SFM MEDICAL DEVICES GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WEST PHARMACEUTICAL SERVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
YUKON MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 1680 |
Port | 759 |
Device Contamination With Chemical Or Other Material | 430 |
Bags | 209 |
Seal | 180 |
Device Operates Differently Than Expected | 53 |
Adapter (Adaptor) | 51 |
Hole In Material | 46 |
Disconnection | 40 |
Break | 36 |
Connector | 32 |
Cap | 24 |
Tube | 22 |
Material Rupture | 21 |
Insufficient Information | 18 |
Material Puncture / Hole | 18 |
Material Perforation | 16 |
Contamination / Decontamination Problem | 13 |
Leak / Splash | 12 |
Failure To Align | 9 |
Valve | 9 |
Delivered As Unsterile Product | 8 |
Cut In Material | 8 |
Filling Problem | 8 |
Improper Flow Or Infusion | 7 |
Connection Problem | 7 |
Cannula | 7 |
Material Separation | 6 |
Material Opacification | 5 |
Device Markings / Labelling Problem | 5 |
Misassembled | 5 |
Material Split, Cut Or Torn | 5 |
Tear, Rip Or Hole In Device Packaging | 4 |
Defective Device | 4 |
Detachment Of Device Or Device Component | 4 |
Loose Or Intermittent Connection | 3 |
Clamp | 3 |
Fitting Problem | 3 |
Chemical Spillage | 3 |
Component Missing | 3 |
Material Integrity Problem | 2 |
Product Quality Problem | 2 |
Device Operational Issue | 2 |
Reflux Within Device | 2 |
Crack | 2 |
Needle | 2 |
Device Slipped | 1 |
Kinked | 1 |
Free Or Unrestricted Flow | 1 |
Scratched Material | 1 |
Material Deformation | 1 |
Incomplete Or Inadequate Connection | 1 |
Detachment Of Device Component | 1 |
Device Emits Odor | 1 |
Unsealed Device Packaging | 1 |
Device Packaging Compromised | 1 |
Material Twisted / Bent | 1 |
Failure To Prime | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
No Flow | 1 |
No Apparent Adverse Event | 1 |
Use Of Device Problem | 1 |
Stopcock | 1 |
Degraded | 1 |
Label | 1 |
Component Misassembled | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3810 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | B. Braun Medical, Inc. | II | Jun-02-2016 |
| 2 | Baxter Corporation Englewood | I | Oct-06-2016 |
| 3 | Baxter Healthcare Corp. | II | Jul-01-2014 |
| 4 | Baxter Healthcare Corporation | II | May-22-2018 |
| 5 | Excelsior Medical Corp | II | Jul-16-2014 |
| 6 | Medimop Medical Projects Ltd. | II | Mar-12-2018 |
| 7 | WEST PHARMA. SERVICES IL, LTD | I | Jan-28-2019 |