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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
2019 137 144
2020 80 80
2021 130 130
2022 77 77
2023 91 91
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 150 150
Break 97 102
Leak/Splash 97 97
Mechanical Problem 83 83
Application Program Problem: Dose Calculation Error 49 49
Output Problem 41 41
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Disconnection 35 35
Application Program Problem 30 30
Inadequate User Interface 24 24
Product Quality Problem 24 24
Device Contamination with Chemical or Other Material 13 15
Defective Component 10 10
Crack 10 10
Contamination 8 8
Contamination of Device Ingredient or Reagent 7 7
Component Missing 7 7
Air/Gas in Device 7 7
Unexpected Shutdown 6 6
Improper or Incorrect Procedure or Method 5 5
Failure to Align 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Material Split, Cut or Torn 5 5
Microbial Contamination of Device 5 5
Loose or Intermittent Connection 5 5
Incorrect Measurement 5 5
Precipitate in Device or Device Ingredient 4 4
Thermal Decomposition of Device 4 4
Fail-Safe Problem 4 4
Difficult to Open or Close 4 4
Wireless Communication Problem 4 4
Detachment of Device or Device Component 3 3
Contamination /Decontamination Problem 3 3
Expiration Date Error 3 3
Material Twisted/Bent 3 3
Application Program Problem: Medication Error 3 3
Device Alarm System 3 3
Device Emits Odor 3 3
Material Opacification 2 2
Application Program Problem: Parameter Calculation Error 2 2
Fracture 2 2
Corroded 2 2
Labelling, Instructions for Use or Training Problem 2 2
Pumping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Data Problem 2 2
Defective Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Markings/Labelling Problem 2 2
Inaccurate Information 2 2
Unexpected Color 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Device Dislodged or Dislocated 1 1
Communication or Transmission Problem 1 1
Calibration Problem 1 1
Inaccurate Delivery 1 1
Device Displays Incorrect Message 1 1
Date/Time-Related Software Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 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
Material Integrity Problem 1 1
Material Fragmentation 1 1
No Display/Image 1 1
Filling Problem 1 1
Defective Alarm 1 1
Use of Incorrect Control/Treatment Settings 1 1
Degraded 1 1
Material Rupture 1 1
Short Fill 1 1
Smoking 1 1
Use of Device Problem 1 1
Unsealed Device Packaging 1 1
Device Difficult to Program or Calibrate 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 270 270
No Known Impact Or Consequence To Patient 129 129
No Patient Involvement 88 94
Insufficient Information 23 23
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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