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TPLC
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Device
set, blood transfusion
Product Code
BRZ
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTERIOCYTE MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
2
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
108
108
2015
171
171
2016
78
78
2017
82
82
2018
66
66
2019
85
99
2020
90
90
2021
60
60
2022
55
55
2023
67
67
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
361
371
Disconnection
151
156
No Flow
47
47
Break
41
41
Crack
40
40
Leak/Splash
36
36
Filling Problem
31
31
Device Operates Differently Than Expected
30
30
Device Contamination with Chemical or Other Material
25
25
Failure to Prime
25
25
Hole In Material
19
19
Detachment Of Device Component
18
18
Material Puncture/Hole
18
18
Material Deformation
16
16
Backflow
14
14
Connection Problem
13
13
Detachment of Device or Device Component
12
12
Cut In Material
12
12
Failure to Disconnect
10
10
Device Displays Incorrect Message
10
10
Improper Flow or Infusion
10
11
Air Leak
10
10
Material Separation
9
9
Material Split, Cut or Torn
9
9
Fitting Problem
8
8
Component Missing
8
8
Failure to Infuse
8
8
Infusion or Flow Problem
7
7
Reflux within Device
7
7
Defective Component
6
6
Obstruction of Flow
5
5
Kinked
5
5
Melted
5
5
Complete Blockage
5
5
Fracture
4
4
Material Rupture
4
4
Improper or Incorrect Procedure or Method
4
4
Material Perforation
4
4
Material Twisted/Bent
4
4
Protective Measures Problem
4
4
Scratched Material
3
3
Defective Device
3
3
Material Integrity Problem
3
3
Free or Unrestricted Flow
3
3
Contamination /Decontamination Problem
3
3
Air/Gas in Device
3
3
Component Misassembled
2
2
Physical Resistance/Sticking
2
2
Separation Failure
2
2
Device Damaged Prior to Use
2
2
Tear, Rip or Hole in Device Packaging
2
2
Insufficient Flow or Under Infusion
2
2
Misconnection
2
2
Occlusion Within Device
2
2
Excess Flow or Over-Infusion
2
2
Loose or Intermittent Connection
2
2
Mechanical Problem
2
2
Partial Blockage
2
2
Component Falling
2
2
Contamination
1
1
Material Discolored
1
1
Clumping in Device or Device Ingredient
1
1
Gas Output Problem
1
1
Inflation Problem
1
1
Difficult to Flush
1
1
Unsealed Device Packaging
1
1
Particulates
1
1
Device Difficult to Setup or Prepare
1
1
Difficult to Remove
1
1
Product Quality Problem
1
1
Failure to Deliver
1
1
Structural Problem
1
1
Component or Accessory Incompatibility
1
1
Patient-Device Incompatibility
1
1
Aspiration Issue
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Packaging Compromised
1
1
Material Protrusion/Extrusion
1
1
Torn Material
1
1
Unintended Movement
1
1
Incomplete or Inadequate Connection
1
1
Incomplete or Inadequate Priming
1
1
Difficult or Delayed Separation
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
263
268
No Patient Involvement
260
262
No Clinical Signs, Symptoms or Conditions
176
176
No Known Impact Or Consequence To Patient
145
152
Insufficient Information
9
9
Low Blood Pressure/ Hypotension
4
4
Exposure to Body Fluids
3
3
No Information
3
3
Blood Loss
3
3
Cardiac Arrest
2
2
Death
1
1
Dyspnea
1
1
Hemorrhage/Bleeding
1
1
Bradycardia
1
1
Inflammation
1
1
Overdose
1
1
No Code Available
1
1
Respiratory Arrest
1
1
Discomfort
1
1
Reaction
1
1
Low Oxygen Saturation
1
1
Shaking/Tremors
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Genesis BPS, LLC.
II
Sep-18-2014
2
Hospira Inc.
I
Aug-05-2013
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