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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
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
2017 56 56
2018 269 269
2019 340 340
2020 322 322
2021 566 566
2022 216 216

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 695 695
Failure to Deliver 369 369
Break 163 163
Device Contamination with Chemical or Other Material 127 127
Packaging Problem 83 83
Device Markings/Labelling Problem 78 78
Physical Resistance/Sticking 65 65
Adverse Event Without Identified Device or Use Problem 49 49
Device Damaged Prior to Use 37 37
Fluid/Blood Leak 30 30
Volume Accuracy Problem 29 29
Short Fill 23 23
Infusion or Flow Problem 22 22
Crack 19 19
Loose or Intermittent Connection 18 18
Material Deformation 18 18
Defective Device 17 17
Component Missing 16 16
Nonstandard Device 16 16
Detachment of Device or Device Component 16 16
Difficult to Advance 15 15
Contamination 15 15
Defective Component 15 15
Material Discolored 12 12
Microbial Contamination of Device 11 11
Material Separation 11 11
Insufficient Information 11 11
Appropriate Term/Code Not Available 10 10
Device Operates Differently Than Expected 10 10
Missing Information 10 10
Patient-Device Incompatibility 10 10
Partial Blockage 10 10
Delivered as Unsterile Product 10 10
Mechanical Problem 9 9
Complete Blockage 9 9
Difficult to Flush 9 9
Air/Gas in Device 9 9
Material Protrusion/Extrusion 8 8
Disconnection 8 8
Product Quality Problem 8 8
Contamination /Decontamination Problem 6 6
Fungus in Device Environment 6 6
Physical Resistance 6 6
Device Packaging Compromised 5 5
Improper Flow or Infusion 5 5
Illegible Information 5 5
Detachment Of Device Component 5 5
Device Emits Odor 4 4
Unsealed Device Packaging 4 4
Tear, Rip or Hole in Device Packaging 4 4
Failure to Advance 4 4
Inappropriate Audible Prompt/Feedback 4 4
Contamination of Device Ingredient or Reagent 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Twisted/Bent 4 4
Free or Unrestricted Flow 3 3
Out-Of-Box Failure 3 3
Device Displays Incorrect Message 3 3
Backflow 3 3
Flushing Problem 3 3
Material Fragmentation 3 3
Air Leak 2 2
Particulates 2 2
Material Opacification 2 2
Melted 2 2
Inability to Irrigate 2 2
Entrapment of Device 2 2
Difficult or Delayed Activation 2 2
Structural Problem 2 2
Device Slipped 2 2
Sticking 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Activation, Positioning or Separation Problem 2 2
Positioning Problem 2 2
Pressure Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Mechanical Jam 1 1
Moisture or Humidity Problem 1 1
No Pressure 1 1
Device Ingredient or Reagent Problem 1 1
Device Sensing Problem 1 1
Compatibility Problem 1 1
Inaccurate Information 1 1
Physical Property Issue 1 1
Sharp Edges 1 1
Audible Prompt/Feedback Problem 1 1
Priming Problem 1 1
Separation Problem 1 1
Unexpected Color 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Problem with Sterilization 1 1
Unable to Obtain Readings 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 690 690
No Known Impact Or Consequence To Patient 555 555
No Consequences Or Impact To Patient 239 239
No Patient Involvement 111 111
No Information 46 46
Insufficient Information 27 27
Bacterial Infection 20 20
Unspecified Infection 19 19
Hypersensitivity/Allergic reaction 10 10
Swelling 9 9
Reaction 8 8
Death 7 7
Rash 6 6
Vomiting 6 6
No Code Available 5 5
Nausea 5 5
Pain 5 5
Dyspnea 5 5
Fever 4 4
Itching Sensation 4 4
Sepsis 4 4
Laceration(s) 3 3
Anaphylactic Shock 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
Burning Sensation 2 2
Dizziness 2 2
Cyanosis 2 2
Exposure to Body Fluids 2 2
Cardiac Arrest 2 2
Headache 2 2
Edema 2 2
Erythema 2 2
Septic Shock 2 2
Skin Irritation 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Urinary Tract Infection 1 1
Memory Loss/Impairment 1 1
High Blood Pressure/ Hypertension 1 1
Inflammation 1 1
Irritation 1 1
Hemorrhage/Bleeding 1 1
Gangrene 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Syncope 1 1
Air Embolism 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Convulsion/Seizure 1 1
Skin Inflammation/ Irritation 1 1
Chills 1 1
Anaphylactoid 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Lethargy 1 1
Loss Of Pulse 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 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 Nurse Assist, Inc I Jan-03-2017
9 Windstone Medical Packaging, Inc. I Oct-29-2021
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