• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device microfilter, blood transfusion
Regulation Description Intravascular administration set.
Product CodeCAK
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2016 97 97
2017 131 131
2018 58 58
2019 334 334
2020 180 180
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 464 464
Coagulation in Device or Device Ingredient 302 302
Filtration Problem 205 205
Defective Component 163 163
Restricted Flow rate 105 105
High Test Results 97 97
High Readings 72 72
Device Operates Differently Than Expected 41 41
Therapeutic or Diagnostic Output Failure 21 21
Device Contamination with Body Fluid 18 18
Incorrect Or Inadequate Test Results 17 17
Contamination of Device Ingredient or Reagent 11 11
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
Product Quality Problem 8 8
Free or Unrestricted Flow 8 8
Device Ingredient or Reagent Problem 7 7
Insufficient Information 6 6
Contamination 5 5
Material Discolored 5 5
Use of Device Problem 4 4
Inadequate Filtration Process 4 4
Improper Flow or Infusion 4 4
Appropriate Term/Code Not Available 3 3
Misassembly by Users 3 3
No Apparent Adverse Event 3 3
Defective Device 3 3
Obstruction of Flow 3 3
Misassembled 3 3
Break 2 2
Human-Device Interface Problem 2 2
Improper Chemical Reaction 2 2
Contamination /Decontamination Problem 2 2
Protective Measures Problem 2 2
Pressure Problem 1 1
No Flow 1 1
Device Operational Issue 1 1
Fail-Safe Problem 1 1
Fungus in Device Environment 1 1
Invalid Sensing 1 1
Improper Device Output 1 1
Burst Container or Vessel 1 1
Fluid Leak 1 1
Device Expiration Issue 1 1
Nonstandard Device 1 1
Difficult to Remove 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 748 748
No Known Impact Or Consequence To Patient 297 297
No Consequences Or Impact To Patient 71 71
No Clinical Signs, Symptoms or Conditions 14 14
Low Blood Pressure/ Hypotension 4 4
Hemolysis 3 3
Reaction 3 3
Needle Stick/Puncture 3 3
Perforation of Esophagus 1 1
Exposure to Body Fluids 1 1
Pain 1 1
No Information 1 1
Insufficient Information 1 1

-
-