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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
2019 137 144
2020 80 80
2021 130 130
2022 77 77
2023 92 92
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 152 152
Break 99 104
Leak/Splash 97 97
Mechanical Problem 83 83
Application Program Problem: Dose Calculation Error 50 50
Output Problem 41 41
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Disconnection 35 35
Application Program Problem 31 31
Inadequate User Interface 25 25
Product Quality Problem 25 25
Device Contamination with Chemical or Other Material 16 18
Crack 10 10
Defective Component 10 10
Component Missing 9 9
Contamination 8 8
Contamination of Device Ingredient or Reagent 8 8
Air/Gas in Device 7 7
Unexpected Shutdown 6 6
Loose or Intermittent Connection 6 6
Microbial Contamination of Device 5 5
Failure to Align 5 5
Improper or Incorrect Procedure or Method 5 5
Incorrect Measurement 5 5
Material Split, Cut or Torn 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Fail-Safe Problem 4 4
Difficult to Open or Close 4 4
Precipitate in Device or Device Ingredient 4 4
Detachment of Device or Device Component 4 4
Thermal Decomposition of Device 4 4
Wireless Communication Problem 4 4
Device Emits Odor 3 3
Application Program Problem: Medication Error 3 3
Device Alarm System 3 3
Material Twisted/Bent 3 3
Expiration Date Error 3 3
Contamination /Decontamination Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Fracture 2 2
Data Problem 2 2
Corroded 2 2
Application Program Problem: Parameter Calculation Error 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Markings/Labelling Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Defective Device 2 2
Inaccurate Information 2 2
Material Opacification 2 2
Pumping Problem 2 2
Protective Measures Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Unexpected Color 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Nonstandard Device 1 1
Inaccurate Delivery 1 1
Calibration Problem 1 1
Filling Problem 1 1
Free or Unrestricted Flow 1 1
Short Fill 1 1
Defective Alarm 1 1
Material Rupture 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Compatibility Problem 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Power Problem 1 1
Date/Time-Related Software Problem 1 1
Infusion or Flow Problem 1 1
Human-Device Interface Problem 1 1
Communication or Transmission Problem 1 1
Degraded 1 1
No Flow 1 1
No Display/Image 1 1
Use of Device Problem 1 1
Smoking 1 1
Device Dislodged or Dislocated 1 1
Device Difficult to Program or Calibrate 1 1
Device Displays Incorrect Message 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 284 284
No Known Impact Or Consequence To Patient 129 129
No Patient Involvement 88 94
Insufficient Information 24 24
No Consequences Or Impact To Patient 5 6
Hyperglycemia 4 4
Electrolyte Imbalance 3 3
Dehydration 1 1
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical, Inc. II Dec-23-2020
2 Baxter Healthcare Corporation I Jul-22-2022
3 OmniCell, Inc. II May-22-2023
4 Smiths Medical ASD Inc. II Apr-21-2021
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