Set, Blood Transfusion

Device Code: 2530

Product Code(s): BRZ

Device Classification Information

Device Type ID2530
Device NameSet, Blood Transfusion
Regulation DescriptionIntravascular Administration Set.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(k)
CFR Regulation Number880.5440 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBRZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2530
DeviceSet, Blood Transfusion
Product CodeBRZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIntravascular Administration Set.
CFR Regulation Number880.5440 [🔎]
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
TPLC Last Update: 2019-04-02 20:13:50

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.