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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 279 279

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 759 759
Failure to Deliver 385 385
Break 166 166
Device Contamination with Chemical or Other Material 127 127
Physical Resistance/Sticking 122 122
Device Markings/Labelling Problem 107 107
Packaging Problem 91 91
Defective Component 71 71
Material Separation 59 59
Adverse Event Without Identified Device or Use Problem 50 50
Fluid/Blood Leak 38 38
Volume Accuracy Problem 37 37
Crack 34 34
Mechanical Problem 33 33
Contamination 32 32
Short Fill 29 29
Material Deformation 26 26
Defective Device 26 26
Missing Information 24 24
Infusion or Flow Problem 23 23
Loose or Intermittent Connection 21 21
Detachment of Device or Device Component 16 16
Difficult to Flush 15 15
Component Missing 14 14
Complete Blockage 13 13
Appropriate Term/Code Not Available 12 12
Fracture 12 12
Partial Blockage 12 12
Delivered as Unsterile Product 11 11
Difficult to Advance 10 10
Air/Gas in Device 9 9
Material Protrusion/Extrusion 8 8
Disconnection 8 8
Patient-Device Incompatibility 8 8
Contamination of Device Ingredient or Reagent 7 7
Illegible Information 7 7
Contamination /Decontamination Problem 7 7
Material Integrity Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Fragmentation 6 6
Material Discolored 6 6
Material Twisted/Bent 6 6
Microbial Contamination of Device 5 5
Device Damaged Prior to Use 5 5
Nonstandard Device 5 5
Fungus in Device Environment 5 5
Insufficient Information 4 4
Inappropriate Audible Prompt/Feedback 4 4
Improper Flow or Infusion 4 4
Connection Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1296 1296
No Known Impact Or Consequence To Patient 402 402
No Consequences Or Impact To Patient 163 163
No Patient Involvement 87 87
Insufficient Information 60 60
No Information 27 27
Bacterial Infection 18 18
Unspecified Infection 13 13
Pain 9 9
Hypersensitivity/Allergic reaction 9 9
Sepsis 7 7
Swelling 7 7
Reaction 6 6
Nausea 6 6
Vomiting 5 5
Laceration(s) 4 4
Dyspnea 4 4
Fever 4 4
Anaphylactic Shock 3 3
Tachycardia 3 3
Swelling/ Edema 3 3
Exposure to Body Fluids 3 3
Confusion/ Disorientation 3 3
Chemical Exposure 3 3
No Code Available 3 3
Death 3 3
Blood Loss 2 2
Itching Sensation 2 2
Purulent Discharge 2 2
Rash 2 2
Burning Sensation 2 2
Underdose 2 2
Malaise 2 2
Chest Pain 2 2
Septic Shock 2 2
Hemorrhage/Bleeding 2 2
Dizziness 2 2
Numbness 2 2
Shaking/Tremors 2 2
Pneumonia 2 2
Cyanosis 2 2
Air Embolism 2 2
Convulsion/Seizure 1 1
Skin Tears 1 1
Renal Failure 1 1
Headache 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Urinary Tract Infection 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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