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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 16 16
2020 4 4
2021 11 11
2022 27 27
2023 36 36
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Fluid/Blood Leak 20 20
Insufficient Information 14 14
Adverse Event Without Identified Device or Use Problem 11 11
Detachment of Device or Device Component 8 8
Fail-Safe Problem 3 3
Material Puncture/Hole 3 3
Leak/Splash 3 3
Material Deformation 3 3
Air/Gas in Device 3 3
Device Displays Incorrect Message 2 2
Fracture 2 2
Crack 2 2
Disconnection 1 1
Complete Blockage 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Reflux within Device 1 1
Difficult to Remove 1 1
Material Separation 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Gas/Air Leak 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Output Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Hemorrhage/Bleeding 20 20
Foreign Body In Patient 13 13
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 7 7
Device Embedded In Tissue or Plaque 5 5
No Consequences Or Impact To Patient 3 3
Needle Stick/Puncture 3 3
Hematoma 2 2
No Information 1 1
Hematuria 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Discomfort 1 1
Ventilator Dependent 1 1
Obstruction/Occlusion 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Neurological Deficit/Dysfunction 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Death 1 1
Embolus 1 1

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