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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 62 62
Activation, Positioning or Separation Problem 43 43
Positioning Failure 28 28
Adverse Event Without Identified Device or Use Problem 23 23
Fluid/Blood Leak 21 21
Insufficient Information 16 16
Positioning Problem 10 10
Detachment of Device or Device Component 10 10
Leak/Splash 6 6
Fracture 5 5
Device Operates Differently Than Expected 4 4
Improper or Incorrect Procedure or Method 4 4
Material Separation 4 4
Device Issue 4 4
Device Displays Incorrect Message 4 4
Material Puncture/Hole 3 3
Protective Measures Problem 3 3
Material Deformation 3 3
Component Missing 3 3
Malposition of Device 3 3
Labelling, Instructions for Use or Training Problem 3 3
Fail-Safe Problem 3 3
Air/Gas in Device 3 3
Difficult to Remove 3 3
Chemical Problem 2 2
Material Frayed 2 2
Fitting Problem 2 2
Deformation Due to Compressive Stress 2 2
Blocked Connection 2 2
Physical Resistance 2 2
No Device Output 2 2
Material Fragmentation 2 2
Hole In Material 2 2
Separation Failure 2 2
Crack 2 2
Tear, Rip or Hole in Device Packaging 1 1
Partial Blockage 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Inadequacy of Device Shape and/or Size 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Detachment Of Device Component 1 1
Kinked 1 1
Wire(s), breakage of 1 1
Complete Blockage 1 1
Uncoiled 1 1
Torn Material 1 1
Device Inoperable 1 1
Connection 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 34 34
Device Embedded In Tissue or Plaque 28 28
No Known Impact Or Consequence To Patient 26 26
Hemorrhage/Bleeding 23 23
Needle Stick/Puncture 23 23
No Information 16 16
Foreign Body In Patient 16 16
Death 8 8
Pneumothorax 7 7
Insufficient Information 7 7
Hematoma 5 5
Infiltration into Tissue 5 5
Phlebitis 4 4
No Code Available 3 3
Blood Loss 3 3
Multiple Organ Failure 3 3
Injury 3 3
Septic Shock 3 3
Patient Problem/Medical Problem 2 2
Low Blood Pressure/ Hypotension 2 2
Skin Irritation 2 2
Venipuncture 2 2
Foreign body, removal of 2 2
Tissue Damage 2 2
Dyspnea 2 2
Exposure to Body Fluids 2 2
Chest Pain 2 2
No Patient Involvement 2 2
Discomfort 2 2
Embolus 1 1
Respiratory Failure 1 1
Ventilator Dependent 1 1
Thromboembolism 1 1
Breathing difficulties 1 1
Headache 1 1
Underdose 1 1
Hypoxia 1 1
Tachycardia 1 1
Ecchymosis 1 1
Swelling 1 1
Loss Of Pulse 1 1
Irritation 1 1
Intracranial Hemorrhage 1 1
Aortic Dissection 1 1
Staphylococcus Aureus 1 1
Neurological Deficit/Dysfunction 1 1
Cardiac Arrest 1 1
Pericardial Effusion 1 1
Obstruction/Occlusion 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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