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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
AM USA
  SUBSTANTIALLY EQUIVALENT 2
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMUSA
  SUBSTANTIALLY EQUIVALENT 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANYANG PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
EXCELSIOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXCELSIOR MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IND NDIAGNOSTIC INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDEFIL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDXL INC.
  SUBSTANTIALLY EQUIVALENT 4
NURSE ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
NURSE ASSIST, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENTAFERTE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRA MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPM MEDICARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 25 25
2015 14 14
2016 82 82
2017 56 56
2018 269 269
2019 340 340
2020 322 322
2021 566 566
2022 282 282
2023 334 334
2024 190 190

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 756 756
Failure to Deliver 385 385
Break 213 213
Device Contamination with Chemical or Other Material 167 167
Physical Resistance/Sticking 133 133
Device Markings/Labelling Problem 115 115
Packaging Problem 99 99
Adverse Event Without Identified Device or Use Problem 70 70
Defective Component 65 65
Fluid/Blood Leak 52 52
Microbial Contamination of Device 51 51
Material Separation 48 48
Device Damaged Prior to Use 40 40
Volume Accuracy Problem 37 37
Mechanical Problem 37 37
Crack 37 37
Contamination 35 35
Appropriate Term/Code Not Available 35 35
Material Deformation 30 30
Short Fill 30 30
Defective Device 27 27
Nonstandard Device 24 24
Component Missing 23 23
Infusion or Flow Problem 23 23
Missing Information 23 23
Loose or Intermittent Connection 21 21
Insufficient Information 20 20
Detachment of Device or Device Component 19 19
Difficult to Advance 19 19
Patient-Device Incompatibility 15 15
Difficult to Flush 15 15
Device Operates Differently Than Expected 14 14
Material Discolored 13 13
Complete Blockage 12 12
Partial Blockage 12 12
Material Fragmentation 12 12
Delivered as Unsterile Product 12 12
Tear, Rip or Hole in Device Packaging 10 10
Fracture 10 10
Material Protrusion/Extrusion 10 10
Contamination /Decontamination Problem 9 9
Air/Gas in Device 9 9
Disconnection 9 9
Product Quality Problem 8 8
Detachment Of Device Component 7 7
Illegible Information 7 7
Contamination of Device Ingredient or Reagent 7 7
Device Packaging Compromised 7 7
Device Contaminated During Manufacture or Shipping 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Material Twisted/Bent 6 6
Connection Problem 6 6
Physical Resistance 6 6
Unsealed Device Packaging 6 6
Fungus in Device Environment 6 6
Material Integrity Problem 5 5
Improper Flow or Infusion 5 5
Failure to Advance 4 4
Structural Problem 4 4
Inappropriate Audible Prompt/Feedback 4 4
Particulates 4 4
Air Leak 4 4
Device Emits Odor 4 4
Material Opacification 3 3
Flushing Problem 3 3
Backflow 3 3
Component Incompatible 3 3
Out-Of-Box Failure 3 3
Free or Unrestricted Flow 3 3
Device Displays Incorrect Message 3 3
Difficult to Open or Remove Packaging Material 3 3
Activation, Positioning or Separation Problem 2 2
Mechanical Jam 2 2
Mechanics Altered 2 2
Moisture or Humidity Problem 2 2
Positioning Problem 2 2
Pressure Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Patient Device Interaction Problem 2 2
Obstruction of Flow 2 2
Difficult or Delayed Activation 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Use of Device Problem 2 2
Device Slipped 2 2
Problem with Sterilization 2 2
Sticking 2 2
Entrapment of Device 2 2
Filling Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Inability to Irrigate 2 2
Hole In Material 2 2
Melted 2 2
Unintended System Motion 1 1
Image Display Error/Artifact 1 1
Excess Flow or Over-Infusion 1 1
Display or Visual Feedback Problem 1 1
Degraded 1 1
Positioning Failure 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1217 1217
No Known Impact Or Consequence To Patient 564 564
No Consequences Or Impact To Patient 243 243
No Patient Involvement 130 130
Bacterial Infection 81 81
No Information 50 50
Insufficient Information 49 49
Unspecified Infection 39 39
Pain 14 14
Hypersensitivity/Allergic reaction 14 14
Vomiting 14 14
Reaction 12 12
Nausea 12 12
Death 12 12
Fever 10 10
Swelling 10 10
Sepsis 9 9
Rash 7 7
Dyspnea 7 7
Exposure to Body Fluids 6 6
No Code Available 6 6
Chemical Exposure 5 5
Chills 5 5
Dizziness 5 5
Septic Shock 4 4
Tachycardia 4 4
Malaise 4 4
Loss of consciousness 4 4
Anaphylactic Shock 4 4
Itching Sensation 4 4
Laceration(s) 4 4
Headache 3 3
Erythema 3 3
Chest Pain 3 3
Burning Sensation 3 3
Sweating 3 3
Swelling/ Edema 3 3
Patient Problem/Medical Problem 2 2
Blood Loss 2 2
Numbness 2 2
Shaking/Tremors 2 2
Underdose 2 2
Confusion/ Disorientation 2 2
Anaphylactoid 2 2
Discomfort 2 2
Cyanosis 2 2
Purulent Discharge 2 2
Edema 2 2
Air Embolism 2 2
Cardiac Arrest 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 2 2
Respiratory Distress 2 2
Renal Failure 1 1
Memory Loss/Impairment 1 1
Inflammation 1 1
Irritation 1 1
Hypoxia 1 1
High Blood Pressure/ Hypertension 1 1
Gangrene 1 1
Cardiopulmonary Arrest 1 1
Syncope 1 1
Abscess 1 1
Endocarditis 1 1
Diarrhea 1 1
Complaint, Ill-Defined 1 1
Weakness 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tinnitus 1 1
Urinary Tract Infection 1 1
Shock 1 1
Skin Irritation 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Skin Tears 1 1
Fungal Infection 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Alteration In Body Temperature 1 1
Convulsion/Seizure 1 1
Skin Inflammation/ Irritation 1 1
Drug Resistant Bacterial Infection 1 1
Injection Site Reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Amsino Medical USA III Sep-15-2012
2 Becton Dickinson & Company II Jan-17-2024
3 Becton Dickinson & Company II May-21-2020
4 Becton Dickinson & Company II Nov-20-2019
5 Becton Dickinson & Company II Sep-22-2014
6 Cardinal Health I Aug-21-2021
7 Centurion Medical Products Corporation II Sep-19-2014
8 Covidien LLC II Sep-01-2015
9 Covidien LLC II Sep-10-2013
10 Covidien LP II Dec-09-2010
11 Excelsior Medical Corp I Oct-20-2010
12 Excelsior Medical Corp II Feb-06-2009
13 Family Dollar Stores, Llc. II Aug-17-2022
14 Hospira Inc. II Jan-11-2012
15 MEDLINE INDUSTRIES, LP - Northfield II Apr-08-2022
16 MRP, LLC dba AMUSA II Aug-27-2015
17 MRP, LLC dba AMUSA II Jun-15-2015
18 MRP, LLC dba AMUSA II Jun-04-2015
19 MRP, LLC dba Aquabiliti II Feb-22-2024
20 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
21 Medline Industries Inc II Aug-29-2018
22 Merit Medical Systems, Inc. I Feb-20-2014
23 Merit Medical Systems, Inc. II Jan-10-2013
24 Nurse Assist, Inc I Jan-03-2017
25 Nurse Assist, LLC I Dec-20-2023
26 Windstone Medical Packaging, Inc. I Oct-29-2021
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