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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
2016 2 2
2017 17 17
2018 45 45
2019 81 81
2020 40 40
2021 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 57 57
Device Contamination with Chemical or Other Material 49 49
Incorrect, Inadequate or Imprecise Resultor Readings 20 20
Short Fill 13 13
Device Markings/Labelling Problem 8 8
Incorrect Or Inadequate Test Results 8 8
Volume Accuracy Problem 7 7
Tear, Rip or Hole in Device Packaging 6 6
False Positive Result 5 5
Break 4 4
Crack 4 4
Unsealed Device Packaging 4 4
Improper or Incorrect Procedure or Method 4 4
Material Deformation 4 4
Detachment Of Device Component 3 3
Component Missing 3 3
Overfill 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Incorrect Measurement 2 2
Appropriate Term/Code Not Available 2 2
Difficult to Insert 2 2
Coagulation in Device or Device Ingredient 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Difficult or Delayed Activation 1 1
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Nonstandard Device 1 1
No Device Output 1 1
Difficult to Remove 1 1
Filling Problem 1 1
Fluid Leak 1 1
Mechanical Jam 1 1
Structural Problem 1 1
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 136 136
No Consequences Or Impact To Patient 20 20
No Clinical Signs, Symptoms or Conditions 16 16
No Information 13 13
No Patient Involvement 9 9
Needle Stick/Puncture 4 4
No Code Available 2 2
Exposure to Body Fluids 1 1
Test Result 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Medical Division II Aug-25-2018
2 Centurion Medical Products Corporation II Feb-05-2020
3 Covidien LLC II Dec-14-2016
4 Thermo Fisher Scientific (Monterrey) II May-26-2020
5 Thermo Fisher Scientific (Monterrey) II Nov-01-2019
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