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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
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 10 10
2022 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 21 21
Manufacturing, Packaging or Shipping Problem 8 8
Nonstandard Device 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Microbial Contamination of Device 4 4
Patient-Device Incompatibility 3 3
Device Contamination with Chemical or Other Material 3 3
Insufficient Information 3 3
Leak/Splash 3 3
Missing Information 2 2
Packaging Problem 2 2
Volume Accuracy Problem 2 2
Device Damaged Prior to Use 1 1
Defective Component 1 1
Delivered as Unsterile Product 1 1
Break 1 1
Crack 1 1
Unintended Ejection 1 1
Fluid Leak 1 1
Hole In Material 1 1
Protective Measures Problem 1 1
Contamination /Decontamination Problem 1 1
Failure to Deliver 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18 18
No Clinical Signs, Symptoms or Conditions 10 10
Insufficient Information 9 9
No Patient Involvement 6 6
Nausea 4 4
Sepsis 3 3
Bacterial Infection 3 3
Reaction 3 3
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
Septic Shock 2 2
Respiratory Distress 2 2
Seizures 2 2
Pain 1 1
Swelling 1 1
Thrombosis 1 1
Vomiting 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Cardiac Arrest 1 1
Alteration In Body Temperature 1 1
Complaint, Ill-Defined 1 1
Malaise 1 1
Numbness 1 1
Abdominal Pain 1 1
No Information 1 1
Constipation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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