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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
2019 51 51
2020 21 21
2021 27 27
2022 39 39
2023 25 25
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 32 32
Short Fill 26 26
Device Contamination with Chemical or Other Material 20 20
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Device Markings/Labelling Problem 13 13
Missing Information 13 13
Material Protrusion/Extrusion 10 10
Volume Accuracy Problem 10 10
Product Quality Problem 9 9
Fluid/Blood Leak 8 8
Delivered as Unsterile Product 5 5
Material Deformation 5 5
Physical Resistance/Sticking 4 4
Break 4 4
Material Discolored 3 3
Component Missing 3 3
Overfill 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 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
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
Fracture 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 79
No Known Impact Or Consequence To Patient 50 50
Needle Stick/Puncture 15 15
No Consequences Or Impact To Patient 9 9
No Patient Involvement 5 5
No Information 3 3
Exposure to Body Fluids 2 2
Laceration(s) 1 1
Pain 1 1
Injury 1 1
Blood Loss 1 1

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