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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 130 130
2022 77 77
2023 92 92
2024 46 46
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 88 88
Break 84 84
Application Program Problem: Dose Calculation Error 47 47
Disconnection 35 35
Leak/Splash 31 31
Application Program Problem 31 31
Inadequate User Interface 25 25
Product Quality Problem 25 25
Device Contamination with Chemical or Other Material 20 20
Mechanical Problem 17 17
Output Problem 13 13
Component Missing 10 10
Defective Component 10 10
Crack 10 10
Contamination of Device Ingredient or Reagent 9 9
Contamination 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Air/Gas in Device 8 8
Loose or Intermittent Connection 7 7
Precipitate in Device or Device Ingredient 7 7
Unexpected Shutdown 6 6
Difficult to Open or Close 5 5
Detachment of Device or Device Component 5 5
Microbial Contamination of Device 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Wireless Communication Problem 4 4
Fail-Safe Problem 4 4
Failure to Align 4 4
Material Split, Cut or Torn 4 4
Device Alarm System 3 3
Expiration Date Error 3 3
Incorrect Measurement 3 3
Contamination /Decontamination Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Material Twisted/Bent 3 3
Application Program Problem: Medication Error 3 3
Corroded 2 2
Fracture 2 2
Tear, Rip or Hole in Device Packaging 2 2
Improper or Incorrect Procedure or Method 2 2
Application Program Problem: Parameter Calculation Error 2 2
Device Emits Odor 2 2
Unexpected Color 2 2
Data Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Device Markings/Labelling Problem 2 2
Infusion or Flow Problem 1 1
Thermal Decomposition of Device 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 310 310
No Patient Involvement 54 54
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 24 24
Hyperglycemia 4 4
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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