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TPLC
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Device
heparin, 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
NZW
Regulation Number
880.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
APP PHARMACEUTICALS, LLC
SUBSTANTIALLY EQUIVALENT
1
BECTON DICKINSON & CO.
SUBSTANTIALLY EQUIVALENT
1
BECTON DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
EXCELSIOR MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
1. K133446
HEPARIN LOCK / FLUSH SYRINGES
MEDEFIL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
5
5
2017
3
3
2018
19
19
2019
19
19
2020
2
2
2021
10
10
2022
14
14
2023
9
9
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Markings/Labelling Problem
23
23
Nonstandard Device
9
9
Manufacturing, Packaging or Shipping Problem
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Packaging Problem
5
5
Device Operates Differently Than Expected
4
4
Device Contamination with Chemical or Other Material
4
4
Patient-Device Incompatibility
4
4
Insufficient Information
4
4
Leak/Splash
4
4
Microbial Contamination of Device
4
4
Missing Information
3
3
Lack of Effect
2
2
Volume Accuracy Problem
2
2
Off-Label Use
2
2
Break
2
2
Crack
2
2
Disconnection
1
1
Unintended Ejection
1
1
Fluid/Blood Leak
1
1
Flushing Problem
1
1
Hole In Material
1
1
Labelling, Instructions for Use or Training Problem
1
1
Shipping Damage or Problem
1
1
Short Fill
1
1
Delivered as Unsterile Product
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Failure to Deliver
1
1
Defective Device
1
1
Appropriate Term/Code Not Available
1
1
Contamination /Decontamination Problem
1
1
Incorrect Device Or Component Shipped
1
1
Protective Measures Problem
1
1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
22
22
No Clinical Signs, Symptoms or Conditions
20
20
Insufficient Information
10
10
No Patient Involvement
6
6
Bacterial Infection
5
5
Fever
5
5
Unspecified Infection
4
4
Nausea
4
4
Sepsis
3
3
Death
3
3
Reaction
3
3
Sweating
2
2
Chemical Exposure
2
2
Seizures
2
2
No Consequences Or Impact To Patient
2
2
No Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Diarrhea
2
2
Hemorrhage/Bleeding
2
2
Septic Shock
2
2
Respiratory Distress
2
2
Staphylococcus Aureus
1
1
Pain
1
1
Swelling
1
1
Thrombosis
1
1
Vomiting
1
1
Chills
1
1
Hypersensitivity/Allergic reaction
1
1
Inflammation
1
1
Cardiac Arrest
1
1
Constipation
1
1
Alteration In Body Temperature
1
1
Foreign Body In Patient
1
1
Complaint, Ill-Defined
1
1
Malaise
1
1
Abdominal Pain
1
1
Numbness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
App Pharmaceuticals Llc
II
Jun-19-2012
2
Excelsior Medical Corp
II
Jun-14-2016
3
Excelsior Medical Corp
II
Jun-05-2012
4
Fresenius Kabi USA, LLC
II
Jan-29-2015
5
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
6
Medefil Incorporated
III
Mar-06-2014
7
Medefil Incorporated
II
Dec-10-2010
8
Vygon Corporation
II
Jun-13-2012
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