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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
MDR Year
MDR Reports
MDR Events
2018
276
276
2019
145
145
2020
147
147
2021
55
55
2022
42
42
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Short Fill
216
216
Volume Accuracy Problem
110
110
Device Contamination with Chemical or Other Material
110
110
Leak/Splash
86
86
Device Markings/Labelling Problem
45
45
Incorrect Or Inadequate Test Results
39
39
Incorrect, Inadequate or Imprecise Result or Readings
38
38
Filling Problem
31
31
Coagulation in Device or Device Ingredient
23
23
Material Deformation
23
23
Overfill
18
18
Output Problem
8
8
Product Quality Problem
8
8
Fluid/Blood Leak
7
7
Improper or Incorrect Procedure or Method
7
7
Suction Problem
7
7
Crack
6
6
Difficult to Insert
4
4
Delivered as Unsterile Product
4
4
Break
3
3
Decrease in Suction
3
3
Therapeutic or Diagnostic Output Failure
3
3
Incorrect Measurement
2
2
Nonstandard Device
2
2
High Test Results
2
2
Use of Device Problem
2
2
Device Contamination with Body Fluid
2
2
Defective Device
2
2
Device Displays Incorrect Message
2
2
Contamination /Decontamination Problem
1
1
Detachment of Device or Device Component
1
1
Device Ingredient or Reagent Problem
1
1
Device Operates Differently Than Expected
1
1
High Readings
1
1
Expiration Date Error
1
1
Defective Component
1
1
Microbial Contamination of Device
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
Suction Failure
1
1
Separation Problem
1
1
Missing Information
1
1
Material Protrusion/Extrusion
1
1
Improper Chemical Reaction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
399
399
No Clinical Signs, Symptoms or Conditions
75
75
Insufficient Information
61
61
No Consequences Or Impact To Patient
57
57
No Patient Involvement
43
43
No Information
29
29
No Code Available
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hemolysis
1
1
Toxicity
1
1
Irritability
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
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