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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
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 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANYANG PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDXL INC.
  SUBSTANTIALLY EQUIVALENT 2
NURSE ASSIST, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENTAFERTE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 269 269
2019 340 340
2020 322 322
2021 566 566
2022 282 282
2023 210 210

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 725 725
Failure to Deliver 383 383
Break 184 184
Device Contamination with Chemical or Other Material 125 125
Physical Resistance/Sticking 107 107
Device Markings/Labelling Problem 95 95
Packaging Problem 90 90
Adverse Event Without Identified Device or Use Problem 57 57
Defective Component 49 49
Device Damaged Prior to Use 34 34
Volume Accuracy Problem 31 31
Fluid/Blood Leak 30 30
Short Fill 28 28
Material Separation 24 24
Crack 24 24
Contamination 23 23
Infusion or Flow Problem 22 22
Material Deformation 20 20
Defective Device 20 20
Loose or Intermittent Connection 19 19
Difficult to Advance 19 19
Detachment of Device or Device Component 18 18
Missing Information 18 18
Nonstandard Device 16 16
Component Missing 15 15
Difficult to Flush 12 12
Partial Blockage 12 12
Complete Blockage 11 11
Material Discolored 11 11
Microbial Contamination of Device 11 11
Patient-Device Incompatibility 10 10
Delivered as Unsterile Product 10 10
Insufficient Information 10 10
Appropriate Term/Code Not Available 10 10
Material Protrusion/Extrusion 9 9
Air/Gas in Device 9 9
Mechanical Problem 9 9
Disconnection 8 8
Physical Resistance 6 6
Tear, Rip or Hole in Device Packaging 6 6
Illegible Information 6 6
Contamination /Decontamination Problem 6 6
Contamination of Device Ingredient or Reagent 6 6
Material Twisted/Bent 5 5
Improper Flow or Infusion 5 5
Fungus in Device Environment 5 5
Failure to Advance 4 4
Inappropriate Audible Prompt/Feedback 4 4
Detachment Of Device Component 4 4
Device Operates Differently Than Expected 4 4
Device Packaging Compromised 4 4
Free or Unrestricted Flow 3 3
Component Incompatible 3 3
Backflow 3 3
Flushing Problem 3 3
Unsealed Device Packaging 3 3
Out-Of-Box Failure 3 3
Structural Problem 3 3
Obstruction of Flow 2 2
Difficult or Delayed Activation 2 2
Device Slipped 2 2
Problem with Sterilization 2 2
Product Quality Problem 2 2
Device Emits Odor 2 2
Material Opacification 2 2
Melted 2 2
Inability to Irrigate 2 2
Entrapment of Device 2 2
Mechanical Jam 2 2
Difficult to Open or Remove Packaging Material 2 2
Activation, Positioning or Separation Problem 2 2
Patient Device Interaction Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Inaccurate Information 1 1
Wrong Label 1 1
Unexpected Color 1 1
Pressure Problem 1 1
Pumping Problem 1 1
Physical Property Issue 1 1
No Pressure 1 1
Component Misassembled 1 1
Sharp Edges 1 1
Audible Prompt/Feedback Problem 1 1
Priming Problem 1 1
Separation Problem 1 1
Device Ingredient or Reagent Problem 1 1
Moisture or Humidity Problem 1 1
Compatibility Problem 1 1
Filling Problem 1 1
Unintended System Motion 1 1
Particulates 1 1
Difficult To Position 1 1
Precipitate in Device or Device Ingredient 1 1
Increase in Pressure 1 1
Failure to Prime 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 946 946
No Known Impact Or Consequence To Patient 534 534
No Consequences Or Impact To Patient 223 223
No Patient Involvement 102 102
No Information 43 43
Insufficient Information 32 32
Bacterial Infection 20 20
Unspecified Infection 20 20
Pain 10 10
Hypersensitivity/Allergic reaction 9 9
Swelling 8 8
Reaction 8 8
Vomiting 7 7
Death 7 7
Sepsis 5 5
Nausea 5 5
No Code Available 5 5
Laceration(s) 4 4
Rash 4 4
Dyspnea 4 4
Fever 4 4
Anaphylactic Shock 3 3
Itching Sensation 3 3
Chemical Exposure 3 3
Swelling/ Edema 3 3
Loss of consciousness 3 3
Sweating 2 2
Underdose 2 2
Confusion/ Disorientation 2 2
Dizziness 2 2
Burning Sensation 2 2
Numbness 2 2
Discomfort 2 2
Blood Loss 2 2
Shaking/Tremors 2 2
Septic Shock 2 2
Cyanosis 2 2
Cardiac Arrest 2 2
Air Embolism 2 2
Edema 2 2
Erythema 2 2
Gangrene 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Syncope 1 1
Exposure to Body Fluids 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Skin Irritation 1 1
Memory Loss/Impairment 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Urinary Tract Infection 1 1
Inflammation 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Skin Tears 1 1
Convulsion/Seizure 1 1
Skin Inflammation/ Irritation 1 1
Injection Site Reaction 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Malaise 1 1
Chills 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 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 Family Dollar Stores, Llc. II Aug-17-2022
5 MEDLINE INDUSTRIES, LP - Northfield II Apr-08-2022
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
7 Medline Industries Inc II Aug-29-2018
8 Windstone Medical Packaging, Inc. I Oct-29-2021
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