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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system/device, pharmacy compounding
Product CodeNEP
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2017 27 27
2018 65 66
2019 137 144
2020 80 80
2021 130 130
2022 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 132 132
Leak/Splash 102 102
Break 95 101
Mechanical Problem 83 83
Application Program Problem: Dose Calculation Error 45 45
Output Problem 41 41
Disconnection 38 38
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Failure to Align 16 16
Defective Component 11 11
Crack 11 11
Improper or Incorrect Procedure or Method 10 10
Device Contamination with Chemical or Other Material 9 11
Improper Flow or Infusion 7 7
Component Missing 7 7
Contamination 6 6
Hole In Material 6 6
Loose or Intermittent Connection 6 6
Incorrect Measurement 5 5
Microbial Contamination of Device 5 5
Thermal Decomposition of Device 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Material Split, Cut or Torn 4 4
Air/Gas in Device 4 4
Precipitate in Device or Device Ingredient 4 4
Material Puncture/Hole 4 4
Device Markings/Labelling Problem 4 4
Material Integrity Problem 4 4
Material Twisted/Bent 3 3
Contamination /Decontamination Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Expiration Date Error 3 3
Defective Device 3 3
Product Quality Problem 3 3
Device Emits Odor 3 3
Use of Device Problem 3 3
Application Program Problem: Parameter Calculation Error 2 2
Material Opacification 2 2
Device Alarm System 2 2
Degraded 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Operates Differently Than Expected 2 2
Pumping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Application Program Problem: Medication Error 2 2
Inaccurate Information 2 2
Unexpected Color 1 1
Physical Resistance/Sticking 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Free or Unrestricted Flow 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Data Problem 1 1
Patient Data Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Detachment of Device or Device Component 1 1
Communication or Transmission Problem 1 1
Cut In Material 1 1
Inaccurate Delivery 1 1
Device Displays Incorrect Message 1 1
Application Program Problem 1 1
Calibration Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1
Defective Alarm 1 1
Labelling, Instructions for Use or Training Problem 1 1
Fracture 1 1
Material Fragmentation 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Filling Problem 1 1
Unsealed Device Packaging 1 1
Melted 1 1
Misassembled 1 1
Material Rupture 1 1
Short Fill 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 172 172
No Known Impact Or Consequence To Patient 149 149
No Patient Involvement 143 150
Insufficient Information 19 19
No Consequences Or Impact To Patient 12 13
No Information 7 7
Hyperglycemia 5 5
Electrolyte Imbalance 2 2
Complaint, Ill-Defined 1 1
Liver Damage/Dysfunction 1 1
Death 1 1
Dehydration 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical, Inc. II Dec-23-2020
2 B. Braun Medical, Inc. II Jul-03-2018
3 Baxter Healthcare Corporation I Jul-22-2022
4 HEALTH ROBOTICS S.R.L. II Jan-10-2017
5 Smiths Medical ASD Inc. II Apr-21-2021
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