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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
2017 27 27
2018 65 66
2019 137 144
2020 80 80
2021 130 130
2022 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 125 125
Leak/Splash 101 101
Break 91 97
Mechanical Problem 83 83
Application Program Problem: Dose Calculation Error 43 43
Output Problem 40 40
Disconnection 38 38
Incorrect, Inadequate or Imprecise Resultor Readings 37 37
Failure to Align 16 16
Defective Component 11 11
Crack 11 11
Improper or Incorrect Procedure or Method 10 10
Device Contamination with Chemical or Other Material 8 10
Improper Flow or Infusion 7 7
Hole In Material 6 6
Component Missing 6 6
Microbial Contamination of Device 5 5
Incorrect Measurement 5 5
Thermal Decomposition of Device 5 5
Contamination 5 5
Material Puncture/Hole 4 4
Device Markings/Labelling Problem 4 4
Material Integrity Problem 4 4
Material Split, Cut or Torn 4 4
Air/Gas in Device 4 4
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Expiration Date Error 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Product Quality Problem 3 3
Device Emits Odor 3 3
Precipitate in Device or Device Ingredient 3 3
Use of Device Problem 3 3
Loose or Intermittent Connection 3 3
Device Alarm System 2 2
Degraded 2 2
Material Opacification 2 2
Application Program Problem: Parameter Calculation Error 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Operates Differently Than Expected 2 2
Device Dislodged or Dislocated 2 2
Pumping Problem 2 2
Inaccurate Information 2 2
Unexpected Color 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Physical Resistance/Sticking 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Therapeutic or Diagnostic Output Failure 1 1
Data Problem 1 1
Patient Data Problem 1 1
Application Program Problem: Medication Error 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Communication or Transmission Problem 1 1
Device Displays Incorrect Message 1 1
Application Program Problem 1 1
Calibration Problem 1 1
Unsealed Device Packaging 1 1
Melted 1 1
Misassembled 1 1
Short Fill 1 1
Smoking 1 1
Inaccurate Delivery 1 1
Cut In Material 1 1
No Display/Image 1 1
Defective Alarm 1 1
Labelling, Instructions for Use or Training Problem 1 1
Electrical /Electronic Property Problem 1 1
Filling Problem 1 1
Fracture 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 149 149
No Clinical Signs, Symptoms or Conditions 149 149
No Patient Involvement 143 150
Insufficient Information 17 17
No Consequences Or Impact To Patient 12 13
No Information 7 7
Hyperglycemia 3 3
Electrolyte Imbalance 2 2
Complaint, Ill-Defined 1 1
Liver Damage/Dysfunction 1 1
Death 1 1
Dehydration 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical, Inc. II Dec-23-2020
2 B. Braun Medical, Inc. II Jul-03-2018
3 HEALTH ROBOTICS S.R.L. II Jan-10-2017
4 Smiths Medical ASD Inc. II Apr-21-2021
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