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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNZW
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
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 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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