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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device container, specimen, sterile
Product CodeFMH
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2019 81 81
2020 40 40
2021 22 22
2022 20 20
2023 43 43
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 51 51
Device Contamination with Chemical or Other Material 43 43
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Short Fill 18 18
Difficult to Remove 9 9
Device Markings/Labelling Problem 8 8
Volume Accuracy Problem 7 7
Unsealed Device Packaging 7 7
Tear, Rip or Hole in Device Packaging 6 6
False Positive Result 5 5
Component Missing 4 4
Material Deformation 4 4
Separation Problem 4 4
Break 4 4
Fluid/Blood Leak 3 3
Improper or Incorrect Procedure or Method 3 3
Compatibility Problem 2 2
Contamination 2 2
Device Ingredient or Reagent Problem 2 2
Material Twisted/Bent 2 2
Fracture 2 2
Overfill 2 2
Appropriate Term/Code Not Available 2 2
Incorrect Measurement 2 2
Coagulation in Device or Device Ingredient 2 2
Defective Device 2 2
Material Separation 2 2
Material Protrusion/Extrusion 1 1
Protective Measures Problem 1 1
Device-Device Incompatibility 1 1
Fitting Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Nonstandard Device 1 1
Insufficient Information 1 1
No Device Output 1 1
Filling Problem 1 1
Crack 1 1
Difficult or Delayed Activation 1 1
Difficult to Insert 1 1
Failure to Seal 1 1
Connection Problem 1 1
Contamination /Decontamination Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Infusion or Flow Problem 1 1
Defective Component 1 1
Material Discolored 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 86 86
No Clinical Signs, Symptoms or Conditions 82 82
No Consequences Or Impact To Patient 17 17
No Patient Involvement 7 7
Insufficient Information 7 7
No Information 7 7
Needle Stick/Puncture 3 3
Hypersensitivity/Allergic reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Exposure to Body Fluids 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
4 Meridian Bioscience Inc II Dec-08-2023
5 Thermo Fisher Scientific (Monterrey) II May-26-2020
6 Thermo Fisher Scientific (Monterrey) II Nov-01-2019
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