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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubes, vacuum sample, with anticoagulant
Product CodeGIM
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
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 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Short Fill 259 259
Device Contamination with Chemical or Other Material 114 114
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
Suction Problem 8 8
Output Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Break 7 7
Difficult to Insert 5 5
Delivered as Unsterile Product 4 4
Device Contamination with Body Fluid 4 4
Decrease in Suction 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Ingredient or Reagent Problem 2 2
Device Operates Differently Than Expected 2 2
Detachment Of Device Component 2 2
Incorrect Measurement 2 2
Nonstandard Device 2 2
Use of Device Problem 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
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
Material Protrusion/Extrusion 1 1
Improper Chemical Reaction 1 1
Insufficient Information 1 1
Suction Failure 1 1
Separation Problem 1 1
Missing Information 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 136 136
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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