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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
Regulation Description Blood specimen collection device.
Product CodeGIM
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 55 55
2022 42 42
2023 33 33
2024 316 316
2025 652 652
2026 275 275

Device Problems MDRs with this Device Problem Events in those MDRs
Short Fill 418 418
Device Contamination with Chemical or Other Material 187 187
Coagulation in Device or Device Ingredient 160 160
Leak/Splash 119 119
Improper Chemical Reaction 84 84
Material Protrusion/Extrusion 58 58
Clumping in Device or Device Ingredient 55 55
Premature Separation 37 37
Incorrect, Inadequate or Imprecise Result or Readings 36 36
Device Ingredient or Reagent Problem 34 34
Excessive Heating 31 31
Difficult to Insert 29 29
Material Deformation 28 28
Fluid/Blood Leak 15 15
Device Markings/Labelling Problem 15 15
Crack 13 13
Device Contamination with Body Fluid 8 8
Break 8 8
Overfill 7 7
Component Misassembled 7 7
Defective Component 6 6
Contamination 6 6
Device Misassembled During Manufacturing /Shipping 6 6
Separation Problem 6 6
Filling Problem 5 5
Device Damaged Prior to Use 5 5
Backflow 4 4
Expiration Date Error 3 3
Product Quality Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Detachment of Device or Device Component 3 3
Improper or Incorrect Procedure or Method 3 3
Material Discolored 2 2
Infusion or Flow Problem 2 2
Missing Information 2 2
Material Split, Cut or Torn 2 2
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Component Missing 1 1
Material Separation 1 1
Volume Accuracy Problem 1 1
Off-Label Use 1 1
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1322 1322
Insufficient Information 47 47
No Consequences Or Impact To Patient 2 2
Irritability 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Greiner Bio-One North America, Inc. II Oct-28-2025
2 Greiner Bio-One North America, Inc. II Sep-22-2021
3 Greiner Bio-One North America, Inc. II May-06-2021
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