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TPLC
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show TPLC since
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Device
cannula, catheter
Product Code
DQR
Regulation Number
870.1300
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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