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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system/device, pharmacy compounding
Product CodeNEP
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2018 65 66
2019 137 144
2020 80 80
2021 130 130
2022 78 78
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 133 133
Leak/Splash 102 102
Break 93 99
Mechanical Problem 83 83
Application Program Problem: Dose Calculation Error 46 46
Output Problem 41 41
Disconnection 37 37
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Failure to Align 18 18
Defective Component 11 11
Crack 11 11
Contamination 8 8
Device Contamination with Chemical or Other Material 8 10
Improper Flow or Infusion 7 7
Component Missing 7 7
Improper or Incorrect Procedure or Method 7 7
Loose or Intermittent Connection 6 6
Incorrect Measurement 5 5
Thermal Decomposition of Device 5 5
Microbial Contamination of Device 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Air/Gas in Device 4 4
Material Split, Cut or Torn 4 4
Material Puncture/Hole 4 4
Device Markings/Labelling Problem 4 4
Precipitate in Device or Device Ingredient 4 4
Device Emits Odor 3 3
Device Alarm System 3 3
Hole In Material 3 3
Material Integrity Problem 3 3
Material Twisted/Bent 3 3
Use of Device Problem 3 3
Expiration Date Error 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Tear, Rip or Hole in Device Packaging 2 2
Device Dislodged or Dislocated 2 2
Labelling, Instructions for Use or Training Problem 2 2
Degraded 2 2
Material Opacification 2 2
Corroded 2 2
Application Program Problem: Parameter Calculation Error 2 2
Pumping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Data Problem 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
Device Difficult to Program or Calibrate 1 1
Material Rupture 1 1
Short Fill 1 1
Smoking 1 1
Unsealed Device Packaging 1 1
Melted 1 1
Misassembled 1 1
Nonstandard Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Defective Alarm 1 1
Fracture 1 1
Material Fragmentation 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Filling Problem 1 1
Free or Unrestricted Flow 1 1
Human-Device Interface Problem 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Communication or Transmission Problem 1 1
Device Displays Incorrect Message 1 1
Calibration Problem 1 1
Product Quality Problem 1 1
Inaccurate Delivery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 188 188
No Known Impact Or Consequence To Patient 145 145
No Patient Involvement 125 132
Insufficient Information 19 19
No Consequences Or Impact To Patient 12 13
No Information 6 6
Hyperglycemia 5 5
Electrolyte Imbalance 3 3
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 Smiths Medical ASD Inc. II Apr-21-2021
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