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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device saline, vascular access flush
Regulation Description Intravascular catheter.
Definition Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Product CodeNGT
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDXL INC.
  SUBSTANTIALLY EQUIVALENT 2
NURSE ASSIST, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 82 82
2017 56 56
2018 269 269
2019 340 340
2020 322 322
2021 530 530

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 660 660
Failure to Deliver 347 347
Break 126 126
Device Contamination with Chemical or Other Material 118 118
Packaging Problem 84 84
Device Markings/Labelling Problem 64 64
Microbial Contamination of Device 46 46
Adverse Event Without Identified Device or Use Problem 43 43
Device Damaged Prior to Use 36 36
Physical Resistance/Sticking 34 34
Appropriate Term/Code Not Available 28 28
Volume Accuracy Problem 27 27
Fluid Leak 27 27
Infusion or Flow Problem 21 21
Nonstandard Device 20 20
Loose or Intermittent Connection 16 16
Short Fill 16 16
Difficult to Advance 15 15
Material Deformation 13 13
Component Missing 13 13
Material Discolored 12 12
Insufficient Information 12 12
Device Operates Differently Than Expected 11 11
Detachment of Device or Device Component 11 11
Patient-Device Incompatibility 10 10
Material Separation 10 10
Mechanical Problem 9 9
Air/Gas in Device 9 9
Material Protrusion/Extrusion 8 8
Contamination 8 8
Defective Component 8 8
Difficult to Flush 7 7
Product Quality Problem 7 7
Defective Device 7 7
Disconnection 7 7
Material Fragmentation 7 7
Device Contaminated During Manufacture or Shipping 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Device Packaging Compromised 7 7
Physical Resistance 6 6
Contamination /Decontamination Problem 6 6
Delivered as Unsterile Product 6 6
Crack 6 6
Complete Blockage 6 6
Detachment Of Device Component 6 6
Unsealed Device Packaging 5 5
Illegible Information 5 5
Improper Flow or Infusion 4 4
Device Emits Odor 4 4
Partial Blockage 4 4
Backflow 3 3
Air Leak 3 3
Device Displays Incorrect Message 3 3
Inappropriate Audible Prompt/Feedback 3 3
Failure to Advance 3 3
Out-Of-Box Failure 3 3
Fungus in Device Environment 3 3
Tear, Rip or Hole in Device Packaging 3 3
Flushing Problem 3 3
Material Twisted/Bent 3 3
Free or Unrestricted Flow 3 3
Missing Information 3 3
Difficult to Open or Remove Packaging Material 2 2
Connection Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Activation, Positioning or SeparationProblem 2 2
Positioning Problem 2 2
Pressure Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Inability to Irrigate 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Device Slipped 2 2
Sticking 2 2
Structural Problem 2 2
Difficult or Delayed Activation 2 2
Entrapment of Device 2 2
Material Opacification 2 2
Particulates 2 2
Melted 2 2
Hole In Material 1 1
Image Display Error/Artifact 1 1
Labelling, Instructions for Use or Training Problem 1 1
Difficult To Position 1 1
Loss of Power 1 1
Precipitate in Device or Device Ingredient 1 1
Increase in Pressure 1 1
Failure to Prime 1 1
Unintended System Motion 1 1
Filling Problem 1 1
Display or Visual Feedback Problem 1 1
Degraded 1 1
Positioning Failure 1 1
Bent 1 1
Component Falling 1 1
Component Incompatible 1 1
Failure to Align 1 1
Dent in Material 1 1
Obstruction of Flow 1 1
Inaccurate Delivery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 559 559
No Clinical Signs, Symptoms or Conditions 451 451
No Consequences Or Impact To Patient 240 240
No Patient Involvement 122 122
Bacterial Infection 65 65
No Information 47 47
Unspecified Infection 29 29
Insufficient Information 25 25
Death 10 10
Hypersensitivity/Allergic reaction 9 9
Swelling 9 9
Reaction 8 8
Vomiting 7 7
Sepsis 6 6
Pain 6 6
Rash 6 6
Nausea 5 5
Dyspnea 5 5
No Code Available 5 5
Fever 4 4
Itching Sensation 4 4
Burning Sensation 3 3
Loss of consciousness 3 3
Chemical Exposure 3 3
Blood Loss 2 2
Discomfort 2 2
Shaking/Tremors 2 2
Underdose 2 2
Sweating 2 2
Dizziness 2 2
Patient Problem/Medical Problem 2 2
Cyanosis 2 2
Septic Shock 2 2
Edema 2 2
Erythema 2 2
Headache 2 2
Anaphylactic Shock 2 2
Exposure to Body Fluids 2 2
Cardiac Arrest 2 2
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Syncope 1 1
Diarrhea 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Gangrene 1 1
Skin Irritation 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Urinary Tract Infection 1 1
Laceration(s) 1 1
Memory Loss/Impairment 1 1
Inflammation 1 1
Irritation 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Alteration In Body Temperature 1 1
Skin Inflammation/ Irritation 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Chills 1 1
Anaphylactoid 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Complaint, Ill-Defined 1 1
Malaise 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II May-21-2020
2 Becton Dickinson & Company II Nov-20-2019
3 Cardinal Health I Aug-21-2021
4 Medline Industries Inc II Aug-29-2018
5 Nurse Assist, Inc I Jan-03-2017
6 Windstone Medical Packaging, Inc. I Oct-29-2021
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