Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
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 Code
NGT
Regulation Number
880.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
JIANGSU CAINA MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
2
MEDXL INC.
SUBSTANTIALLY EQUIVALENT
2
NURSE ASSIST, LLC
SUBSTANTIALLY EQUIVALENT
1
PENTAFERTE ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
269
269
2019
340
340
2020
322
322
2021
566
566
2022
282
282
2023
210
210
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
725
725
Failure to Deliver
383
383
Break
184
184
Device Contamination with Chemical or Other Material
125
125
Physical Resistance/Sticking
107
107
Device Markings/Labelling Problem
95
95
Packaging Problem
90
90
Adverse Event Without Identified Device or Use Problem
57
57
Defective Component
49
49
Device Damaged Prior to Use
34
34
Volume Accuracy Problem
31
31
Fluid/Blood Leak
30
30
Short Fill
28
28
Material Separation
24
24
Crack
24
24
Contamination
23
23
Infusion or Flow Problem
22
22
Material Deformation
20
20
Defective Device
20
20
Loose or Intermittent Connection
19
19
Difficult to Advance
19
19
Detachment of Device or Device Component
18
18
Missing Information
18
18
Nonstandard Device
16
16
Component Missing
15
15
Difficult to Flush
12
12
Partial Blockage
12
12
Complete Blockage
11
11
Material Discolored
11
11
Microbial Contamination of Device
11
11
Patient-Device Incompatibility
10
10
Delivered as Unsterile Product
10
10
Insufficient Information
10
10
Appropriate Term/Code Not Available
10
10
Material Protrusion/Extrusion
9
9
Air/Gas in Device
9
9
Mechanical Problem
9
9
Disconnection
8
8
Physical Resistance
6
6
Tear, Rip or Hole in Device Packaging
6
6
Illegible Information
6
6
Contamination /Decontamination Problem
6
6
Contamination of Device Ingredient or Reagent
6
6
Material Twisted/Bent
5
5
Improper Flow or Infusion
5
5
Fungus in Device Environment
5
5
Failure to Advance
4
4
Inappropriate Audible Prompt/Feedback
4
4
Detachment Of Device Component
4
4
Device Operates Differently Than Expected
4
4
Device Packaging Compromised
4
4
Free or Unrestricted Flow
3
3
Component Incompatible
3
3
Backflow
3
3
Flushing Problem
3
3
Unsealed Device Packaging
3
3
Out-Of-Box Failure
3
3
Structural Problem
3
3
Obstruction of Flow
2
2
Difficult or Delayed Activation
2
2
Device Slipped
2
2
Problem with Sterilization
2
2
Product Quality Problem
2
2
Device Emits Odor
2
2
Material Opacification
2
2
Melted
2
2
Inability to Irrigate
2
2
Entrapment of Device
2
2
Mechanical Jam
2
2
Difficult to Open or Remove Packaging Material
2
2
Activation, Positioning or Separation Problem
2
2
Patient Device Interaction Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Positioning Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Unintended Movement
2
2
Inaccurate Information
1
1
Wrong Label
1
1
Unexpected Color
1
1
Pressure Problem
1
1
Pumping Problem
1
1
Physical Property Issue
1
1
No Pressure
1
1
Component Misassembled
1
1
Sharp Edges
1
1
Audible Prompt/Feedback Problem
1
1
Priming Problem
1
1
Separation Problem
1
1
Device Ingredient or Reagent Problem
1
1
Moisture or Humidity Problem
1
1
Compatibility Problem
1
1
Filling Problem
1
1
Unintended System Motion
1
1
Particulates
1
1
Difficult To Position
1
1
Precipitate in Device or Device Ingredient
1
1
Increase in Pressure
1
1
Failure to Prime
1
1
Material Fragmentation
1
1
Image Display Error/Artifact
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
946
946
No Known Impact Or Consequence To Patient
534
534
No Consequences Or Impact To Patient
223
223
No Patient Involvement
102
102
No Information
43
43
Insufficient Information
32
32
Bacterial Infection
20
20
Unspecified Infection
20
20
Pain
10
10
Hypersensitivity/Allergic reaction
9
9
Swelling
8
8
Reaction
8
8
Vomiting
7
7
Death
7
7
Sepsis
5
5
Nausea
5
5
No Code Available
5
5
Laceration(s)
4
4
Rash
4
4
Dyspnea
4
4
Fever
4
4
Anaphylactic Shock
3
3
Itching Sensation
3
3
Chemical Exposure
3
3
Swelling/ Edema
3
3
Loss of consciousness
3
3
Sweating
2
2
Underdose
2
2
Confusion/ Disorientation
2
2
Dizziness
2
2
Burning Sensation
2
2
Numbness
2
2
Discomfort
2
2
Blood Loss
2
2
Shaking/Tremors
2
2
Septic Shock
2
2
Cyanosis
2
2
Cardiac Arrest
2
2
Air Embolism
2
2
Edema
2
2
Erythema
2
2
Gangrene
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Syncope
1
1
Exposure to Body Fluids
1
1
Cardiopulmonary Arrest
1
1
Chest Pain
1
1
Skin Irritation
1
1
Memory Loss/Impairment
1
1
Tachycardia
1
1
Therapeutic Effects, Unexpected
1
1
Thrombus
1
1
Urinary Tract Infection
1
1
Inflammation
1
1
Renal Failure
1
1
Respiratory Distress
1
1
Skin Tears
1
1
Convulsion/Seizure
1
1
Skin Inflammation/ Irritation
1
1
Injection Site Reaction
1
1
Alteration In Body Temperature
1
1
Patient Problem/Medical Problem
1
1
Malaise
1
1
Chills
1
1
Lethargy
1
1
Loss Of Pulse
1
1
Low Oxygen Saturation
1
1
Respiratory Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Company
II
May-21-2020
2
Becton Dickinson & Company
II
Nov-20-2019
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
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
7
Medline Industries Inc
II
Aug-29-2018
8
Windstone Medical Packaging, Inc.
I
Oct-29-2021
-
-