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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

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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