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

MDR Year MDR Reports MDR Events
2020 40 40
2021 22 22
2022 20 20
2023 43 43
2024 39 39
2025 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 44 44
Device Contamination with Chemical or Other Material 41 41
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Short Fill 12 12
Device Markings/Labelling Problem 9 9
Difficult to Remove 9 9
Unsealed Device Packaging 7 7
Overfill 6 6
Tear, Rip or Hole in Device Packaging 6 6
Break 5 5
Contamination 5 5
Fluid/Blood Leak 4 4
Separation Problem 4 4
False Positive Result 4 4
Device Ingredient or Reagent Problem 3 3
Volume Accuracy Problem 3 3
Separation Failure 3 3
Component Missing 3 3
Activation, Positioning or Separation Problem 2 2
Compatibility Problem 2 2
Defective Device 2 2
Material Discolored 2 2
Fracture 2 2
Material Separation 2 2
Incorrect Measurement 2 2
Failure to Seal 1 1
No Device Output 1 1
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Coagulation in Device or Device Ingredient 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Device Handling Problem 1 1
Packaging Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Difficult to Insert 1 1
Contamination /Decontamination Problem 1 1
Defective Component 1 1
Insufficient Information 1 1
Filling Problem 1 1
Crack 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 159 159
No Consequences Or Impact To Patient 17 17
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 8 8
No Patient Involvement 6 6
Hypersensitivity/Allergic reaction 2 2
Exposure to Body Fluids 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Rash 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Klinika Mdical Gmb II May-15-2025
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
7 Meridian Bioscience Inc II Dec-08-2023
8 Thermo Fisher Scientific (Monterrey) II May-26-2020
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