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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
Regulation Description Intravascular administration set.
Product CodeNEP
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2020 80 80
2021 130 132
2022 77 77
2023 91 92
2024 46 46
2025 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 89 89
Fluid/Blood Leak 88 88
Application Program Problem: Dose Calculation Error 50 50
Disconnection 35 35
Leak/Splash 31 31
Application Program Problem 31 32
Inadequate User Interface 25 26
Product Quality Problem 25 26
Device Contamination with Chemical or Other Material 19 19
Mechanical Problem 17 17
Output Problem 13 13
Component Missing 12 12
Crack 10 10
Defective Component 10 10
Contamination of Device Ingredient or Reagent 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Contamination 9 9
Loose or Intermittent Connection 8 8
Difficult to Open or Close 8 8
Air/Gas in Device 8 8
Precipitate in Device or Device Ingredient 7 7
Material Split, Cut or Torn 6 6
Unexpected Shutdown 6 6
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Microbial Contamination of Device 5 5
Improper or Incorrect Procedure or Method 4 4
Device Emits Odor 4 4
Failure to Align 4 4
Fail-Safe Problem 4 4
Wireless Communication Problem 4 4
Contamination /Decontamination Problem 3 3
Expiration Date Error 3 3
Material Twisted/Bent 3 3
Application Program Problem: Medication Error 3 3
Fracture 3 3
Labelling, Instructions for Use or Training Problem 3 3
Incorrect Measurement 3 3
Device Alarm System 3 3
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Volume Accuracy Problem 2 2
Corroded 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Inaccurate Delivery 2 2
Data Problem 2 2
Unexpected Color 2 2
Application Program Problem: Parameter Calculation Error 2 2
Filling Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 330 333
No Patient Involvement 54 54
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 24 24
Hyperglycemia 7 7
Electrolyte Imbalance 3 3
No Consequences Or Impact To Patient 2 2
Dehydration 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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