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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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 37 37
Device Contamination with Chemical or Other Material 28 28
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Short Fill 10 10
Difficult to Remove 9 9
Unsealed Device Packaging 7 7
Device Markings/Labelling Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Break 5 5
Contamination 5 5
Separation Problem 4 4
Fluid/Blood Leak 4 4
Overfill 4 4
False Positive Result 3 3
Volume Accuracy Problem 3 3
Device Ingredient or Reagent Problem 3 3
Component Missing 3 3
Separation Failure 3 3
Activation, Positioning or Separation Problem 2 2
Compatibility Problem 2 2
Incorrect Measurement 2 2
Material Separation 2 2
Defective Device 2 2
Fracture 2 2
Connection Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Nonstandard Device 1 1
Protective Measures Problem 1 1
Contamination /Decontamination Problem 1 1
Fitting Problem 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Difficult to Insert 1 1
Defective Component 1 1
No Device Output 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Discolored 1 1
Insufficient Information 1 1
Improper or Incorrect Procedure or Method 1 1
Coagulation in Device or Device Ingredient 1 1
Device-Device Incompatibility 1 1
Filling Problem 1 1
Failure to Seal 1 1
Crack 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 125 125
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
No Code Available 1 1
Rash 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
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 Meridian Bioscience Inc II Dec-08-2023
7 Thermo Fisher Scientific (Monterrey) II May-26-2020
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