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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
2021 22 22
2022 20 20
2023 43 43
2024 39 40
2025 75 75
2026 88 88

Device Problems MDRs with this Device Problem Events in those MDRs
Short Fill 58 58
Device Contamination with Chemical or Other Material 40 40
Incorrect, Inadequate or Imprecise Result or Readings 35 35
Leak/Splash 31 31
Device Markings/Labelling Problem 15 15
Difficult to Remove 9 9
Separation Problem 7 7
Unsealed Device Packaging 7 7
Contamination 6 6
Overfill 6 6
Tear, Rip or Hole in Device Packaging 6 6
Fluid/Blood Leak 6 6
Premature Separation 5 5
Device Ingredient or Reagent Problem 3 3
Separation Failure 3 3
Component Missing 3 3
Material Discolored 2 2
Fracture 2 2
Fitting Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Break 1 1
Volume Accuracy Problem 1 1
Crack 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Difficult to Insert 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Insufficient Device Problem Information 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1
Product Quality Problem 1 1
Material Separation 1 1
Missing Information 1 1
Coagulation in Device or Device Ingredient 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 274 274
Insufficient Information 8 8
Exposure to Body Fluids 2 3
No Consequences Or Impact To Patient 2 2
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Needle Stick/Puncture 1 2
No Patient Involvement 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Klinika Mdical Gmb II May-15-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
6 Medline Industries, LP II May-07-2026
7 Medline Industries, LP II Apr-30-2026
8 Medline Industries, LP II Feb-17-2026
9 Meridian Bioscience Inc II Dec-08-2023
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