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TPLC
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show TPLC since
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Device
catheter, subclavian
Product Code
LFJ
Regulation Number
876.5540
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
31
31
2018
31
31
2019
45
45
2020
43
43
2021
37
37
2022
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Deformation
36
36
Break
23
23
Fluid Leak
16
16
Material Frayed
16
16
Unraveled Material
16
16
Deformation Due to Compressive Stress
12
12
Difficult to Insert
12
12
Leak/Splash
11
11
Physical Resistance/Sticking
10
10
Component Incompatible
7
7
Entrapment of Device
6
6
Fracture
5
5
Defective Component
5
5
Difficult to Remove
5
5
Material Separation
5
5
Gas Leak
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Material Integrity Problem
4
4
Material Puncture/Hole
4
4
Crack
4
4
Occlusion Within Device
3
3
Obstruction of Flow
3
3
Failure to Advance
2
2
Insufficient Information
2
2
Device Damaged Prior to Use
2
2
Kinked
2
2
Material Fragmentation
2
2
Air Leak
2
2
Product Quality Problem
2
2
Failure to Infuse
2
2
Suction Problem
2
2
Detachment of Device or Device Component
2
2
Device Operates Differently Than Expected
1
1
Difficult to Advance
1
1
Device Contamination with Chemical or Other Material
1
1
Fitting Problem
1
1
Dull, Blunt
1
1
Incorrect, Inadequate or Imprecise Resultor Readings
1
1
Material Rupture
1
1
Sticking
1
1
Stretched
1
1
Device Inoperable
1
1
Bent
1
1
Loss of or Failure to Bond
1
1
Positioning Failure
1
1
Failure to Discharge
1
1
Material Discolored
1
1
Disconnection
1
1
Hole In Material
1
1
Mechanical Problem
1
1
Delivered as Unsterile Product
1
1
Material Twisted/Bent
1
1
Suction Failure
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Aspiration Issue
1
1
Infusion or Flow Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
82
82
No Clinical Signs, Symptoms or Conditions
50
50
No Known Impact Or Consequence To Patient
39
39
No Patient Involvement
6
6
Death
4
4
Air Embolism
3
3
Unspecified Infection
3
3
Foreign Body In Patient
3
3
No Information
3
3
Insufficient Information
3
3
No Code Available
2
2
Pain
2
2
Low Oxygen Saturation
2
2
Chest Pain
1
1
Fever
1
1
Hemorrhage/Bleeding
1
1
Unintended Radiation Exposure
1
1
Vessel Or Plaque, Device Embedded In
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medical Components, Inc dba MedComp
II
Aug-08-2019
2
Medical Components, Inc dba MedComp
II
Apr-16-2019
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