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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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 51 51
Device Contamination with Chemical or Other Material 44 44
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
Break 4 4
Component Missing 4 4
Material Deformation 4 4
Separation Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Separation Failure 3 3
Fluid/Blood Leak 3 3
Fracture 2 2
Coagulation in Device or Device Ingredient 2 2
Contamination 2 2
Material Separation 2 2
Incorrect Measurement 2 2
Defective Device 2 2
Overfill 2 2
Device Ingredient or Reagent Problem 2 2
Appropriate Term/Code Not Available 2 2
Compatibility Problem 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Protrusion/Extrusion 1 1
Failure to Seal 1 1
Fitting Problem 1 1
Defective Component 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Difficult or Delayed Activation 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Nonstandard Device 1 1
No Device Output 1 1
Product Quality Problem 1 1
Crack 1 1
Material Discolored 1 1
Difficult to Insert 1 1
Filling 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 83 83
No Consequences Or Impact To Patient 17 17
Insufficient Information 8 8
No Information 7 7
No Patient Involvement 7 7
Needle Stick/Puncture 3 3
Exposure to Body Fluids 1 1
Hypersensitivity/Allergic reaction 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
5 Meridian Bioscience Inc II Dec-08-2023
6 Thermo Fisher Scientific (Monterrey) II May-26-2020
7 Thermo Fisher Scientific (Monterrey) II Nov-01-2019
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