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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 92 92
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 154 154
Break 100 105
Leak/Splash 97 97
Mechanical Problem 83 83
Application Program Problem: Dose Calculation Error 51 51
Output Problem 41 41
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Disconnection 35 35
Application Program Problem 31 31
Product Quality Problem 25 25
Inadequate User Interface 25 25
Device Contamination with Chemical or Other Material 19 21
Defective Component 10 10
Crack 10 10
Component Missing 9 9
Contamination of Device Ingredient or Reagent 8 8
Contamination 8 8
Air/Gas in Device 7 7
Loose or Intermittent Connection 7 7
Unexpected Shutdown 6 6
Microbial Contamination of Device 5 5
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Failure to Align 5 5
Incorrect Measurement 5 5
Improper or Incorrect Procedure or Method 5 5
Difficult to Open or Close 5 5
Material Split, Cut or Torn 5 5
Fail-Safe Problem 4 4
Precipitate in Device or Device Ingredient 4 4
Thermal Decomposition of Device 4 4
Wireless Communication Problem 4 4
Device Emits Odor 3 3
Expiration Date Error 3 3
Device Alarm System 3 3
Material Twisted/Bent 3 3
Application Program Problem: Medication Error 3 3
Contamination /Decontamination Problem 3 3
Pumping Problem 2 2
Device Markings/Labelling Problem 2 2
Inaccurate Information 2 2
Corroded 2 2
Defective Device 2 2
Material Opacification 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Rupture 2 2
Data Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Labelling, Instructions for Use or Training Problem 2 2
Application Program Problem: Parameter Calculation Error 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 293 293
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
No Code Available 1 1
No Information 1 1
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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