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TPLC
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Device
tubes, vacuum sample, with anticoagulant
Product Code
GIM
Regulation Number
862.1675
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECTON DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
2
BECTON, DICKINSON & COMPANY
SUBSTANTIALLY EQUIVALENT
1
CALTAG MEDSYSTEMS LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
2
2
2017
12
12
2018
276
276
2019
145
145
2020
147
147
2021
55
55
2022
42
42
2023
33
33
2024
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Short Fill
260
260
Device Contamination with Chemical or Other Material
115
115
Volume Accuracy Problem
112
112
Leak/Splash
88
88
Device Markings/Labelling Problem
48
48
Incorrect Or Inadequate Test Results
40
40
Incorrect, Inadequate or Imprecise Result or Readings
39
39
Filling Problem
33
33
Coagulation in Device or Device Ingredient
23
23
Material Deformation
23
23
Overfill
18
18
Crack
9
9
Fluid/Blood Leak
8
8
Product Quality Problem
8
8
Improper or Incorrect Procedure or Method
8
8
Suction Problem
8
8
Output Problem
8
8
Break
7
7
Difficult to Insert
5
5
Delivered as Unsterile Product
4
4
Device Contamination with Body Fluid
4
4
Therapeutic or Diagnostic Output Failure
3
3
Decrease in Suction
3
3
Detachment Of Device Component
2
2
Incorrect Measurement
2
2
Nonstandard Device
2
2
Device Damaged Prior to Use
2
2
Defective Component
2
2
High Test Results
2
2
Defective Device
2
2
Device Displays Incorrect Message
2
2
Material Protrusion/Extrusion
2
2
Use of Device Problem
2
2
Device Ingredient or Reagent Problem
2
2
Device Operates Differently Than Expected
2
2
Improper Chemical Reaction
1
1
Insufficient Information
1
1
Suction Failure
1
1
Separation Problem
1
1
Premature Separation
1
1
Missing Information
1
1
Contamination /Decontamination Problem
1
1
Detachment of Device or Device Component
1
1
High Readings
1
1
Expiration Date Error
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Fungus in Device Environment
1
1
Off-Label Use
1
1
Unexpected Therapeutic Results
1
1
Mechanical Problem
1
1
Material Discolored
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
406
406
No Clinical Signs, Symptoms or Conditions
141
141
Insufficient Information
61
61
No Consequences Or Impact To Patient
61
61
No Patient Involvement
43
43
No Information
29
29
No Code Available
2
2
Test Result
2
2
Hemolysis
1
1
Toxicity
1
1
Irritability
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Greiner Bio-One North America, Inc.
II
Sep-22-2021
2
Greiner Bio-One North America, Inc.
II
May-06-2021
3
Greiner Bio-One North America, Inc.
II
Apr-15-2020
4
Greiner Bio-One North America, Inc.
II
Aug-07-2012
5
Streck
II
Mar-08-2017
6
bioMerieux, Inc.
II
Mar-30-2012
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