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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
2015 1 1
2017 42 42
2018 70 70
2019 51 51
2020 21 21
2021 27 27
2022 39 39
2023 25 25
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 56 56
Device Contamination with Chemical or Other Material 45 45
Short Fill 34 34
Device Markings/Labelling Problem 21 21
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Incorrect Or Inadequate Test Results 15 15
Product Quality Problem 13 13
Missing Information 13 13
Material Protrusion/Extrusion 13 13
Fluid/Blood Leak 12 12
Volume Accuracy Problem 12 12
Material Deformation 9 9
Delivered as Unsterile Product 9 9
Component Missing 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Break 5 5
Material Discolored 4 4
Physical Resistance/Sticking 4 4
Mushroomed 2 2
Difficult to Insert 2 2
Contamination of Device Ingredient or Reagent 2 2
Detachment of Device or Device Component 2 2
Out-Of-Box Failure 1 1
Overfill 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 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
Microbial Contamination of Device 1 1
Structural Problem 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Shielding Failure 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Fracture 1 1
Hole In Material 1 1
Complete Blockage 1 1
Detachment Of Device Component 1 1
Component Incompatible 1 1
Contamination 1 1
Crack 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Separation Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 129 129
No Clinical Signs, Symptoms or Conditions 78 78
No Consequences Or Impact To Patient 26 26
Needle Stick/Puncture 25 25
No Information 9 9
No Patient Involvement 5 5
Exposure to Body Fluids 3 3
Laceration(s) 1 1
Pain 1 1
Injury 1 1
No Code Available 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Heritage Labs International LLC II Jan-11-2012
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