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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
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
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
2020 322 322
2021 566 566
2022 282 282
2023 334 334
2024 364 364
2025 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 637 637
Failure to Deliver 382 382
Break 170 170
Device Contamination with Chemical or Other Material 117 117
Physical Resistance/Sticking 104 104
Packaging Problem 86 86
Device Markings/Labelling Problem 84 84
Defective Component 76 76
Material Separation 65 65
Contamination 47 47
Crack 40 40
Adverse Event Without Identified Device or Use Problem 38 38
Fluid/Blood Leak 38 38
Mechanical Problem 30 30
Material Deformation 30 30
Volume Accuracy Problem 30 30
Missing Information 29 29
Short Fill 26 26
Defective Device 25 25
Infusion or Flow Problem 20 20
Loose or Intermittent Connection 18 18
Appropriate Term/Code Not Available 15 15
Difficult to Flush 13 13
Complete Blockage 12 12
Fracture 12 12
Partial Blockage 12 12
Component Missing 12 12
Detachment of Device or Device Component 12 12
Material Integrity Problem 10 10
Air/Gas in Device 9 9
Delivered as Unsterile Product 9 9
Contamination /Decontamination Problem 7 7
Tear, Rip or Hole in Device Packaging 7 7
Material Protrusion/Extrusion 7 7
Material Fragmentation 6 6
Separation Problem 6 6
Material Discolored 5 5
Connection Problem 5 5
Illegible Information 5 5
Contamination of Device Ingredient or Reagent 5 5
Insufficient Information 5 5
Fungus in Device Environment 5 5
Nonstandard Device 5 5
Microbial Contamination of Device 5 5
Material Twisted/Bent 4 4
Difficult to Advance 4 4
Structural Problem 4 4
Disconnection 4 4
Improper Flow or Infusion 3 3
Manufacturing, Packaging or Shipping Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1446 1446
No Consequences Or Impact To Patient 159 159
No Known Impact Or Consequence To Patient 134 134
Insufficient Information 79 79
No Patient Involvement 71 71
Bacterial Infection 17 17
Unspecified Infection 10 10
Pain 7 7
Hypersensitivity/Allergic reaction 6 6
Sepsis 5 5
Laceration(s) 4 4
Anaphylactic Shock 4 4
Confusion/ Disorientation 3 3
No Information 3 3
Swelling/ Edema 3 3
Dyspnea 3 3
Numbness 2 2
Hemorrhage/Bleeding 2 2
Fever 2 2
Purulent Discharge 2 2
Death 2 2
Cyanosis 2 2
Chest Pain 2 2
Exposure to Body Fluids 2 2
Air Embolism 2 2
Dizziness 2 2
Vomiting 2 2
Tachycardia 2 2
Septic Shock 2 2
Pneumonia 2 2
Nausea 2 2
Chemical Exposure 2 2
Burning Sensation 1 1
Bradycardia 1 1
Cardiopulmonary Arrest 1 1
Swelling 1 1
Rash 1 1
Diarrhea 1 1
Memory Loss/Impairment 1 1
Headache 1 1
Itching Sensation 1 1
Unspecified Kidney or Urinary Problem 1 1
Low Blood Pressure/ Hypotension 1 1
Convulsion/Seizure 1 1
Inflammation 1 1
Skin Inflammation/ Irritation 1 1
Drug Resistant Bacterial Infection 1 1
Injection Site Reaction 1 1
No Code Available 1 1
Device Embedded In Tissue or Plaque 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 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 MRP, LLC dba Aquabiliti II Feb-22-2024
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 Nurse Assist, LLC I Dec-20-2023
9 Windstone Medical Packaging, Inc. I Oct-29-2021
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