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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

MDR Year MDR Reports MDR Events
2019 145 145
2020 147 147
2021 55 55
2022 42 42
2023 33 33
2024 181 181

Device Problems MDRs with this Device Problem Events in those MDRs
Short Fill 203 203
Device Contamination with Chemical or Other Material 78 78
Volume Accuracy Problem 61 61
Coagulation in Device or Device Ingredient 54 54
Leak/Splash 52 52
Device Markings/Labelling Problem 42 42
Filling Problem 33 33
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Material Protrusion/Extrusion 17 17
Overfill 14 14
Material Deformation 9 9
Improper or Incorrect Procedure or Method 9 9
Crack 8 8
Product Quality Problem 8 8
Output Problem 8 8
Difficult to Insert 8 8
Fluid/Blood Leak 7 7
Suction Problem 7 7
Defective Component 6 6
Device Contamination with Body Fluid 6 6
Break 6 6
Clumping in Device or Device Ingredient 5 5
Expiration Date Error 4 4
Delivered as Unsterile Product 4 4
Therapeutic or Diagnostic Output Failure 3 3
Decrease in Suction 3 3
Premature Separation 3 3
Defective Device 2 2
Device Damaged Prior to Use 2 2
Missing Information 2 2
Device Displays Incorrect Message 2 2
Device Ingredient or Reagent Problem 2 2
Separation Problem 2 2
Contamination 2 2
Use of Device Problem 2 2
High Test Results 2 2
Nonstandard Device 2 2
Suction Failure 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Incorrect Measurement 1 1
Off-Label Use 1 1
Mechanical Problem 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
High Readings 1 1
Microbial Contamination of Device 1 1
Material Discolored 1 1
Improper Chemical Reaction 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 285 285
No Known Impact Or Consequence To Patient 191 191
Insufficient Information 61 61
No Patient Involvement 42 42
No Consequences Or Impact To Patient 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
No Information 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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