• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device cannula, catheter
Regulation Description Catheter cannula.
Product CodeDQR
Regulation Number 870.1300
Device Class 2

MDR Year MDR Reports MDR Events
2015 40 40
2016 75 75
2017 29 29
2018 16 16
2019 16 16
2020 4 4
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 49 49
Activation, Positioning or SeparationProblem 43 43
Positioning Failure 28 28
Adverse Event Without Identified Device or Use Problem 11 11
Positioning Problem 10 10
Fracture 5 5
Device Issue 4 4
Device Operates Differently Than Expected 4 4
Device Displays Incorrect Message 4 4
Leak/Splash 4 4
Improper or Incorrect Procedure or Method 4 4
Malposition of Device 3 3
Detachment of Device or Device Component 3 3
Protective Measures Problem 3 3
Insufficient Information 3 3
Component Missing 3 3
No Device Output 2 2
Separation Failure 2 2
Physical Resistance 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Material Puncture/Hole 2 2
Difficult to Remove 2 2
Material Separation 2 2
Material Fragmentation 2 2
Fluid Leak 2 2
Chemical Problem 2 2
Material Frayed 2 2
Image Orientation Incorrect 1 1
Difficult to Insert 1 1
Kinked 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Disconnection 1 1
Fail-Safe Design Failure 1 1
Fitting Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Reflux within Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Connection Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Complete Blockage 1 1
Crack 1 1
Hole In Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Migration or Expulsion of Device 1 1
Uncoiled 1 1
Use of Device Problem 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Pumping Stopped 1 1
Device Operational Issue 1 1
Gas Leak 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
No Flow 1 1
Output Problem 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 49 49
Device Embedded In Tissue or Plaque 28 28
No Known Impact Or Consequence To Patient 25 25
Needle Stick/Puncture 21 21
No Information 15 15
Death 8 8
Pneumothorax 6 6
Infiltration into Tissue 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Phlebitis 4 4
Hemorrhage/Bleeding 4 4
No Code Available 3 3
Injury 3 3
Foreign Body In Patient 3 3
Hematoma 3 3
Multiple Organ Failure 3 3
Septic Shock 3 3
Skin Irritation 2 2
Dyspnea 2 2
Insufficient Information 2 2
Patient Problem/Medical Problem 2 2
Blood Loss 2 2
No Patient Involvement 2 2
Chest Pain 2 2
Tissue Damage 2 2
Venipuncture 2 2
Infection, Pyrogenic 1 1
Discomfort 1 1
Respiratory Distress 1 1
Tachycardia 1 1
Hypoxia 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Purulent Discharge 1 1
Ecchymosis 1 1
Embolus 1 1
Hemolysis 1 1
Ventilator Dependent 1 1
Loss Of Pulse 1 1
Exsanguination 1 1
Intracranial Hemorrhage 1 1
Low Blood Pressure/ Hypotension 1 1
Irritation 1 1
Neurological Deficit/Dysfunction 1 1
Staphylococcus Aureus 1 1
Swelling 1 1
Pericardial Effusion 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Breathing difficulties 1 1
Respiratory Failure 1 1
Aortic Dissection 1 1
Underdose 1 1

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