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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
Regulation Description Specimen transport and storage container.
Product CodeKDT
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2020 21 21
2021 27 27
2022 39 39
2023 25 25
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 18 18
Short Fill 14 14
Missing Information 13 13
Device Markings/Labelling Problem 11 11
Device Contamination with Chemical or Other Material 10 10
Volume Accuracy Problem 9 9
Product Quality Problem 8 8
Fluid/Blood Leak 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Delivered as Unsterile Product 6 6
Material Protrusion/Extrusion 6 6
Break 4 4
Physical Resistance/Sticking 4 4
Component Missing 3 3
Material Discolored 3 3
Material Deformation 3 3
Difficult to Insert 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Shielding Failure 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Complete Blockage 1 1
Fracture 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 84 84
Needle Stick/Puncture 11 11
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 8 8
No Patient Involvement 4 4
Exposure to Body Fluids 1 1
Pain 1 1

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