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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


Premarket Reviews
ManufacturerDecision
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 40 40
2016 75 75
2017 29 29
2018 16 16
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 61 61
Activation, Positioning or Separation Problem 43 43
Positioning Failure 28 28
Adverse Event Without Identified Device or Use Problem 22 22
Fluid/Blood Leak 21 21
Insufficient Information 16 16
Positioning Problem 10 10
Detachment of Device or Device Component 10 10
Fracture 5 5
Leak/Splash 5 5
Material Separation 4 4
Improper or Incorrect Procedure or Method 4 4
Device Issue 4 4
Device Operates Differently Than Expected 4 4
Device Displays Incorrect Message 4 4
Malposition of Device 3 3
Fail-Safe Problem 3 3
Protective Measures Problem 3 3
Material Deformation 3 3
Difficult to Remove 3 3
Air/Gas in Device 3 3
Component Missing 3 3
Material Puncture/Hole 3 3
No Device Output 2 2
Fitting Problem 2 2
Crack 2 2
Material Fragmentation 2 2
Material Frayed 2 2
Hole In Material 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Chemical Problem 2 2
Separation Failure 2 2
Physical Resistance 2 2
Device, removal of (non-implant) 1 1
Connection Problem 1 1
Gas/Air Leak 1 1
Device Contaminated During Manufacture or Shipping 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Operational Issue 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Torn Material 1 1
Output Problem 1 1
Image Orientation Incorrect 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Kinked 1 1
Partial Blockage 1 1
Complete Blockage 1 1
Detachment Of Device Component 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Disconnection 1 1
Fail-Safe Design Failure 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Defective Component 1 1
Wire(s), breakage of 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Pumping Stopped 1 1
Reflux within Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Uncoiled 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 50 50
No Clinical Signs, Symptoms or Conditions 31 31
Device Embedded In Tissue or Plaque 28 28
No Known Impact Or Consequence To Patient 26 26
Needle Stick/Puncture 23 23
Hemorrhage/Bleeding 23 23
No Information 16 16
Foreign Body In Patient 15 15
Death 8 8
Pneumothorax 7 7
Insufficient Information 7 7
Hematoma 5 5
Infiltration into Tissue 5 5
Phlebitis 4 4
Septic Shock 3 3
Injury 3 3
No Code Available 3 3
Multiple Organ Failure 3 3
Blood Loss 3 3
No Patient Involvement 2 2
Tissue Damage 2 2
Venipuncture 2 2
Patient Problem/Medical Problem 2 2
Discomfort 2 2
Foreign body, removal of 2 2
Skin Irritation 2 2
Chest Pain 2 2
Low Blood Pressure/ Hypotension 2 2
Exposure to Body Fluids 2 2
Dyspnea 2 2
Ecchymosis 1 1
Embolus 1 1
Exsanguination 1 1
Cardiac Arrest 1 1
Purulent Discharge 1 1
Hypoxia 1 1
Irritation 1 1
Neurological Deficit/Dysfunction 1 1
Hemolysis 1 1
Intracranial Hemorrhage 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1
Swelling 1 1
Tachycardia 1 1
Ventilator Dependent 1 1
Breathing difficulties 1 1
Obstruction/Occlusion 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Infection, Pyrogenic 1 1
Nonresorbable materials, unretrieved in body 1 1
Pericardial Effusion 1 1
Respiratory Failure 1 1
Aortic Dissection 1 1
Underdose 1 1
Hematuria 1 1
Loss Of Pulse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Nov-05-2020
2 Angiodynamics, Inc. II May-25-2013
3 SPS Sterilization, Inc II Sep-13-2018
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