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TPLC
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show TPLC since
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2024
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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
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
Detachment of Device or Device Component
10
10
Positioning Problem
10
10
Leak/Splash
6
6
Fracture
5
5
Device Displays Incorrect Message
4
4
Device Issue
4
4
Improper or Incorrect Procedure or Method
4
4
Device Operates Differently Than Expected
4
4
Material Separation
4
4
Material Puncture/Hole
3
3
Protective Measures Problem
3
3
Labelling, Instructions for Use or Training Problem
3
3
Material Deformation
3
3
Component Missing
3
3
Difficult to Remove
3
3
Air/Gas in Device
3
3
Malposition of Device
3
3
Fail-Safe Problem
3
3
No Device Output
2
2
Hole In Material
2
2
Deformation Due to Compressive Stress
2
2
Material Frayed
2
2
Fitting Problem
2
2
Chemical Problem
2
2
Blocked Connection
2
2
Physical Resistance
2
2
Material Fragmentation
2
2
Separation Failure
2
2
Crack
2
2
Difficult to Insert
1
1
Unraveled Material
1
1
Fail-Safe Design Failure
1
1
Use of Device Problem
1
1
Pumping Stopped
1
1
Gas/Air Leak
1
1
Material Twisted/Bent
1
1
Device Operational Issue
1
1
Device, removal of (non-implant)
1
1
Material Integrity Problem
1
1
Reflux within Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Partial Blockage
1
1
Defective Component
1
1
Migration or Expulsion of Device
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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