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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
Regulation Description Intravascular catheter.
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
BD
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 19 19
2019 19 19
2020 2 2
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 13 13
Nonstandard Device 6 6
Microbial Contamination of Device 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Label 3 3
Leak/Splash 3 3
Patient-Device Incompatibility 3 3
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Packaging Problem 1 1
Cap 1 1
Break 1 1
Crack 1 1
Unintended Ejection 1 1
Fluid Leak 1 1
Hole In Material 1 1
Delivered as Unsterile Product 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 6 6
Bacterial Infection 3 3
Nausea 3 3
Reaction 3 3
Sepsis 3 3
Septic Shock 2 2
No Consequences Or Impact To Patient 2 2
Sweating 2 2
Chemical Exposure 2 2
Unspecified Infection 2 2
Death 2 2
Diarrhea 2 2
Respiratory Distress 2 2
Seizures 2 2
Vomiting 1 1
Complaint, Ill-Defined 1 1
Alteration In Body Temperature 1 1
No Information 1 1
Constipation 1 1
Hemorrhage/Bleeding 1 1
Cardiac Arrest 1 1
Abdominal Pain 1 1
Pain 1 1
Malaise 1 1
Numbness 1 1
Fever 1 1
Inflammation 1 1
Swelling 1 1
Thrombosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Excelsior Medical Corp II Jun-14-2016
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