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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, catheter
Regulation Description Catheter cannula.
Product CodeDQR
Regulation Number 870.1300
Device Class 2

MDR Year MDR Reports MDR Events
2020 4 4
2021 11 11
2022 27 27
2023 36 36
2024 7 7
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 20 20
Break 15 15
Insufficient Information 14 14
Adverse Event Without Identified Device or Use Problem 12 12
Detachment of Device or Device Component 7 7
Air/Gas in Device 3 3
Fail-Safe Problem 3 3
Material Deformation 3 3
Material Puncture/Hole 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Protrusion/Extrusion 2 2
Fracture 2 2
Leak/Splash 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Crack 1 1
Defective Component 1 1
Difficult to Remove 1 1
Material Fragmentation 1 1
Material Twisted/Bent 1 1
Material Separation 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
Hemorrhage/Bleeding 20 20
Foreign Body In Patient 13 13
Insufficient Information 8 8
Hematoma 2 2
Needle Stick/Puncture 2 2
Device Embedded In Tissue or Plaque 2 2
Encephalopathy 1 1
Dysphasia 1 1
Hematuria 1 1
Obstruction/Occlusion 1 1
Cardiac Arrest 1 1
No Known Impact Or Consequence To Patient 1 1
Exposure to Body Fluids 1 1
Discomfort 1 1
Hypoxia 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 1
Thromboembolism 1 1
Low Blood Pressure/ Hypotension 1 1
Ventilator Dependent 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Nov-05-2020
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