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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

MDR Year MDR Reports MDR Events
2018 19 19
2019 19 19
2020 2 2
2021 10 10
2022 14 14
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 22 22
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
Packaging Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Leak/Splash 3 3
Missing Information 2 2
Insufficient Information 2 2
Volume Accuracy Problem 2 2
Break 2 2
Crack 1 1
Disconnection 1 1
Fluid/Blood Leak 1 1
Hole In Material 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Delivered as Unsterile Product 1 1
Shipping Damage or Problem 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 17 17
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 10 10
No Patient Involvement 6 6
Nausea 4 4
Bacterial Infection 3 3
Unspecified Infection 3 3
Death 2 2
Diarrhea 2 2
No Consequences Or Impact To Patient 2 2
Respiratory Distress 2 2
Seizures 2 2
Sepsis 2 2
Septic Shock 2 2
Reaction 2 2
Sweating 2 2
Chemical Exposure 2 2
Alteration In Body Temperature 1 1
Abdominal Pain 1 1
No Information 1 1
Constipation 1 1
Swelling 1 1
Thrombosis 1 1
Vomiting 1 1
Complaint, Ill-Defined 1 1
Malaise 1 1
Pain 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Cardiac Arrest 1 1

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