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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, specimen mailer and storage, sterile
Product CodeKDT
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2018 70 70
2019 51 51
2020 21 21
2021 27 27
2022 39 39
2023 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 52 52
Short Fill 34 34
Device Contamination with Chemical or Other Material 33 33
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Device Markings/Labelling Problem 16 16
Incorrect Or Inadequate Test Results 15 15
Material Protrusion/Extrusion 13 13
Missing Information 13 13
Product Quality Problem 12 12
Volume Accuracy Problem 12 12
Material Deformation 9 9
Fluid/Blood Leak 8 8
Delivered as Unsterile Product 7 7
Break 5 5
Physical Resistance/Sticking 4 4
Component Missing 3 3
Material Discolored 3 3
Difficult to Insert 2 2
Shielding Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Complete Blockage 1 1
Component Incompatible 1 1
Fracture 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Overfill 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 102 102
No Clinical Signs, Symptoms or Conditions 75 75
No Consequences Or Impact To Patient 19 19
Needle Stick/Puncture 17 17
No Information 8 8
No Patient Involvement 5 5
Exposure to Body Fluids 2 2
Laceration(s) 1 1
Pain 1 1
Injury 1 1
No Code Available 1 1
Blood Loss 1 1

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