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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 279 279

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 769 769
Failure to Deliver 385 385
Break 227 227
Device Contamination with Chemical or Other Material 172 172
Physical Resistance/Sticking 133 133
Device Markings/Labelling Problem 124 124
Packaging Problem 103 103
Defective Component 76 76
Adverse Event Without Identified Device or Use Problem 71 71
Material Separation 62 62
Fluid/Blood Leak 55 55
Microbial Contamination of Device 51 51
Device Damaged Prior to Use 40 40
Crack 38 38
Contamination 38 38
Mechanical Problem 37 37
Volume Accuracy Problem 37 37
Appropriate Term/Code Not Available 35 35
Material Deformation 31 31
Short Fill 30 30
Defective Device 27 27
Component Missing 26 26
Nonstandard Device 24 24
Missing Information 24 24
Infusion or Flow Problem 23 23
Loose or Intermittent Connection 21 21
Insufficient Information 21 21
Detachment of Device or Device Component 19 19
Difficult to Advance 19 19
Difficult to Flush 15 15
Patient-Device Incompatibility 15 15
Device Operates Differently Than Expected 14 14
Material Discolored 14 14
Complete Blockage 13 13
Fracture 12 12
Delivered as Unsterile Product 12 12
Partial Blockage 12 12
Material Fragmentation 12 12
Tear, Rip or Hole in Device Packaging 11 11
Disconnection 10 10
Material Protrusion/Extrusion 10 10
Contamination /Decontamination Problem 9 9
Air/Gas in Device 9 9
Product Quality Problem 8 8
Illegible Information 7 7
Device Contaminated During Manufacture or Shipping 7 7
Contamination of Device Ingredient or Reagent 7 7
Device Packaging Compromised 7 7
Detachment Of Device Component 7 7
Material Twisted/Bent 7 7

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 564 564
No Consequences Or Impact To Patient 243 243
No Patient Involvement 130 130
Bacterial Infection 83 83
Insufficient Information 60 60
No Information 50 50
Unspecified Infection 39 39
Pain 14 14
Hypersensitivity/Allergic reaction 14 14
Vomiting 14 14
Reaction 12 12
Death 12 12
Nausea 12 12
Sepsis 11 11
Swelling 10 10
Fever 10 10
Dyspnea 7 7
Rash 7 7
Exposure to Body Fluids 6 6
No Code Available 6 6
Dizziness 5 5
Chills 5 5
Chemical Exposure 5 5
Anaphylactic Shock 4 4
Tachycardia 4 4
Laceration(s) 4 4
Septic Shock 4 4
Itching Sensation 4 4
Malaise 4 4
Loss of consciousness 4 4
Confusion/ Disorientation 3 3
Headache 3 3
Burning Sensation 3 3
Erythema 3 3
Chest Pain 3 3
Sweating 3 3
Swelling/ Edema 3 3
Edema 2 2
Blood Loss 2 2
Purulent Discharge 2 2
Anaphylactoid 2 2
Cardiac Arrest 2 2
Underdose 2 2
Hemorrhage/Bleeding 2 2
Respiratory Distress 2 2
Low Blood Pressure/ Hypotension 2 2
Respiratory Failure 2 2
Diarrhea 2 2
Discomfort 2 2

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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