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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
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 21 21
Manufacturing, Packaging or Shipping Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Missing Information 3 3
Leak/Splash 2 2
Break 2 2
Off-Label Use 2 2
Volume Accuracy Problem 2 2
Insufficient Information 2 2
Lack of Effect 2 2
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Disconnection 1 1
Short Fill 1 1
Failure to Deliver 1 1
Shipping Damage or Problem 1 1
Delivered as Unsterile Product 1 1
Labelling, Instructions for Use or Training Problem 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Flushing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Known Impact Or Consequence To Patient 11 11
Insufficient Information 10 10
No Patient Involvement 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Seizures 2 2
Chemical Exposure 2 2
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Nausea 1 1
Dizziness 1 1
Malaise 1 1
Taste Disorder 1 1
Thrombosis 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1
Low Blood Pressure/ Hypotension 1 1

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