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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
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDXL INC.
  SUBSTANTIALLY EQUIVALENT 3
NURSE ASSIST, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENTAFERTE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SPM MEDICARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 340 340
2020 322 322
2021 566 566
2022 282 282
2023 334 334
2024 219 219

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 750 750
Failure to Deliver 385 385
Break 159 159
Device Contamination with Chemical or Other Material 124 124
Physical Resistance/Sticking 122 122
Device Markings/Labelling Problem 98 98
Packaging Problem 87 87
Defective Component 63 63
Material Separation 50 50
Adverse Event Without Identified Device or Use Problem 50 50
Volume Accuracy Problem 37 37
Fluid/Blood Leak 37 37
Crack 33 33
Mechanical Problem 33 33
Contamination 30 30
Short Fill 29 29
Defective Device 26 26
Material Deformation 25 25
Infusion or Flow Problem 23 23
Missing Information 23 23
Loose or Intermittent Connection 21 21
Detachment of Device or Device Component 16 16
Difficult to Flush 15 15
Partial Blockage 12 12
Complete Blockage 12 12
Appropriate Term/Code Not Available 12 12
Fracture 11 11
Delivered as Unsterile Product 11 11
Component Missing 11 11
Difficult to Advance 10 10
Air/Gas in Device 9 9
Material Protrusion/Extrusion 8 8
Patient-Device Incompatibility 8 8
Disconnection 8 8
Contamination /Decontamination Problem 7 7
Contamination of Device Ingredient or Reagent 7 7
Illegible Information 7 7
Material Fragmentation 6 6
Material Discolored 5 5
Nonstandard Device 5 5
Fungus in Device Environment 5 5
Microbial Contamination of Device 5 5
Tear, Rip or Hole in Device Packaging 5 5
Device Damaged Prior to Use 5 5
Material Twisted/Bent 5 5
Material Integrity Problem 5 5
Inappropriate Audible Prompt/Feedback 4 4
Connection Problem 4 4
Improper Flow or Infusion 4 4
Free or Unrestricted Flow 3 3
Structural Problem 3 3
Material Opacification 3 3
Flushing Problem 3 3
Component Incompatible 3 3
Insufficient Information 3 3
Separation Problem 2 2
Patient Device Interaction Problem 2 2
Difficult or Delayed Activation 2 2
Mechanical Jam 2 2
Therapeutic or Diagnostic Output Failure 2 2
Backflow 2 2
Labelling, Instructions for Use or Training Problem 2 2
Inability to Irrigate 2 2
Melted 2 2
Difficult to Open or Remove Packaging Material 2 2
Obstruction of Flow 2 2
Inaccurate Delivery 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Device Ingredient or Reagent Problem 1 1
Compatibility Problem 1 1
Failure to Advance 1 1
Dent in Material 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or Separation Problem 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Failure to Prime 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Material Rupture 1 1
Excess Flow or Over-Infusion 1 1
Entrapment of Device 1 1
Device Alarm System 1 1
Positioning Failure 1 1
Unintended Movement 1 1
No Pressure 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Pumping Problem 1 1
No Flow 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1242 1242
No Known Impact Or Consequence To Patient 402 402
No Consequences Or Impact To Patient 163 163
No Patient Involvement 87 87
Insufficient Information 52 52
No Information 27 27
Bacterial Infection 18 18
Unspecified Infection 13 13
Hypersensitivity/Allergic reaction 9 9
Pain 9 9
Sepsis 7 7
Swelling 7 7
Nausea 6 6
Reaction 6 6
Vomiting 5 5
Laceration(s) 4 4
Dyspnea 4 4
Fever 4 4
Death 3 3
Exposure to Body Fluids 3 3
Anaphylactic Shock 3 3
Tachycardia 3 3
Confusion/ Disorientation 3 3
Chemical Exposure 3 3
No Code Available 3 3
Swelling/ Edema 3 3
Blood Loss 2 2
Underdose 2 2
Numbness 2 2
Malaise 2 2
Shaking/Tremors 2 2
Burning Sensation 2 2
Dizziness 2 2
Septic Shock 2 2
Pneumonia 2 2
Rash 2 2
Itching Sensation 2 2
Air Embolism 2 2
Chest Pain 2 2
Cyanosis 2 2
Purulent Discharge 2 2
Hemorrhage/Bleeding 2 2
Headache 1 1
Diarrhea 1 1
Edema 1 1
Bradycardia 1 1
Cardiopulmonary Arrest 1 1
Inflammation 1 1
Renal Failure 1 1
Memory Loss/Impairment 1 1
Urinary Tract Infection 1 1
Skin Tears 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Loss Of Pulse 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Convulsion/Seizure 1 1
Unspecified Kidney or Urinary Problem 1 1
Skin Inflammation/ Irritation 1 1
Drug Resistant Bacterial Infection 1 1
Injection Site Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Jan-17-2024
2 Becton Dickinson & Company II May-21-2020
3 Becton Dickinson & Company II Nov-20-2019
4 Cardinal Health I Aug-21-2021
5 Family Dollar Stores, Llc. II Aug-17-2022
6 MEDLINE INDUSTRIES, LP - Northfield II Apr-08-2022
7 MRP, LLC dba Aquabiliti II Feb-22-2024
8 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
9 Nurse Assist, LLC I Dec-20-2023
10 Windstone Medical Packaging, Inc. I Oct-29-2021
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