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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

MDR Year MDR Reports MDR Events
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 174 174
Device Contamination with Chemical or Other Material 66 66
Volume Accuracy Problem 61 61
Leak/Splash 46 46
Device Markings/Labelling Problem 38 38
Filling Problem 33 33
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Overfill 14 14
Product Quality Problem 8 8
Material Deformation 8 8
Output Problem 8 8
Fluid/Blood Leak 7 7
Coagulation in Device or Device Ingredient 7 7
Improper or Incorrect Procedure or Method 7 7
Suction Problem 7 7
Crack 6 6
Break 6 6
Delivered as Unsterile Product 4 4
Difficult to Insert 4 4
Decrease in Suction 3 3
Device Contamination with Body Fluid 3 3
Therapeutic or Diagnostic Output Failure 3 3
Use of Device Problem 2 2
Device Ingredient or Reagent Problem 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Device Damaged Prior to Use 2 2
High Test Results 2 2
Nonstandard Device 2 2
Off-Label Use 1 1
Unexpected Therapeutic Results 1 1
Material Discolored 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
High Readings 1 1
Expiration Date Error 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 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 191 191
No Clinical Signs, Symptoms or Conditions 136 136
Insufficient Information 61 61
No Patient Involvement 42 42
No Consequences Or Impact To Patient 20 20
Irritability 1 1
No Information 1 1
No Code Available 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
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