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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
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
6
6
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
Leak/Splash
4
4
Microbial Contamination of Device
4
4
Device Operates Differently Than Expected
4
4
Patient-Device Incompatibility
4
4
Insufficient Information
4
4
Device Contamination with Chemical or Other Material
4
4
Missing Information
3
3
Volume Accuracy Problem
2
2
Off-Label Use
2
2
Break
2
2
Crack
2
2
Lack of Effect
2
2
Shipping Damage or Problem
1
1
Disconnection
1
1
Failure to Deliver
1
1
Contamination /Decontamination Problem
1
1
Protective Measures Problem
1
1
Appropriate Term/Code Not Available
1
1
Flushing Problem
1
1
Device Damaged Prior to Use
1
1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
1
1
Short Fill
1
1
Defective Device
1
1
Defective Component
1
1
Unintended Ejection
1
1
Incorrect Device Or Component Shipped
1
1
Delivered as Unsterile Product
1
1
Labelling, Instructions for Use or Training Problem
1
1
Fluid/Blood Leak
1
1
Hole In Material
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
Fever
5
5
Bacterial Infection
5
5
Unspecified Infection
4
4
Nausea
4
4
Death
3
3
Sepsis
3
3
Reaction
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Sweating
2
2
Respiratory Distress
2
2
Seizures
2
2
No Information
2
2
Chemical Exposure
2
2
Diarrhea
2
2
Septic Shock
2
2
Hemorrhage/Bleeding
2
2
No Consequences Or Impact To Patient
2
2
Abdominal Pain
1
1
Complaint, Ill-Defined
1
1
Hypersensitivity/Allergic reaction
1
1
Dizziness
1
1
Inflammation
1
1
Malaise
1
1
Taste Disorder
1
1
Staphylococcus Aureus
1
1
Alteration In Body Temperature
1
1
Cardiac Arrest
1
1
Chills
1
1
Foreign Body In Patient
1
1
Numbness
1
1
Swelling
1
1
Vomiting
1
1
Thrombosis
1
1
Pain
1
1
Constipation
1
1
Low Blood Pressure/ Hypotension
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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