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TPLC
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Device
catheter, hemodialysis, triple lumen, non-implanted
Definition
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Product Code
NIE
Regulation Number
876.5540
Device Class
2
Premarket Reviews
Manufacturer
Decision
HEALTH LINE INTERNATIONAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
SUBSTANTIALLY EQUIVALENT - KIT
1
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
MDR Year
MDR Reports
MDR Events
2019
61
61
2020
51
51
2021
61
61
2022
119
119
2023
103
103
2024
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
81
81
Material Deformation
42
42
Material Frayed
40
40
Adverse Event Without Identified Device or Use Problem
39
39
Obstruction of Flow
27
27
Break
26
26
Defective Component
22
22
Material Puncture/Hole
22
22
Detachment of Device or Device Component
18
18
Device Dislodged or Dislocated
16
16
Difficult to Remove
15
15
Product Quality Problem
10
10
Failure to Infuse
10
10
Material Twisted/Bent
10
10
Component Incompatible
9
9
Unraveled Material
8
8
Leak/Splash
7
7
Contamination /Decontamination Problem
7
7
Insufficient Information
6
6
Physical Resistance/Sticking
6
6
Material Fragmentation
6
6
Nonstandard Device
5
5
Gas/Air Leak
5
5
Material Integrity Problem
5
5
Difficult to Insert
4
4
Suction Problem
4
4
Insufficient Flow or Under Infusion
4
4
Failure to Advance
3
3
Collapse
3
3
Disconnection
3
3
Infusion or Flow Problem
3
3
Migration or Expulsion of Device
3
3
Difficult to Advance
3
3
Material Split, Cut or Torn
3
3
Device Markings/Labelling Problem
2
2
Malposition of Device
2
2
Deformation Due to Compressive Stress
2
2
Material Too Rigid or Stiff
2
2
Material Rupture
1
1
Device Slipped
1
1
Improper or Incorrect Procedure or Method
1
1
Defective Device
1
1
Device Displays Incorrect Message
1
1
Structural Problem
1
1
Entrapment of Device
1
1
Fracture
1
1
Crack
1
1
Deflation Problem
1
1
Device Alarm System
1
1
Device Difficult to Setup or Prepare
1
1
Mechanical Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Activation, Positioning or Separation Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Material Protrusion/Extrusion
1
1
Positioning Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Noise, Audible
1
1
Activation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
191
191
No Consequences Or Impact To Patient
58
58
Insufficient Information
52
52
Swelling/ Edema
48
48
Erythema
47
47
No Known Impact Or Consequence To Patient
30
30
Foreign Body In Patient
11
11
Hemorrhage/Bleeding
11
11
Death
7
7
Hematoma
6
6
Unintended Radiation Exposure
4
4
No Patient Involvement
4
4
Blood Loss
3
3
Perforation of Vessels
2
2
No Information
2
2
Cardiac Arrest
2
2
Exsanguination
2
2
Laceration(s)
2
2
Thrombus
1
1
Hemothorax
1
1
Injury
1
1
Obstruction/Occlusion
1
1
Cardiac Perforation
1
1
Fatigue
1
1
Encephalopathy
1
1
Abdominal Pain
1
1
Arrhythmia
1
1
Renal Impairment
1
1
Skin Inflammation/ Irritation
1
1
Radiation Exposure, Unintended
1
1
Device Embedded In Tissue or Plaque
1
1
Great Vessel Perforation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Company
II
Nov-05-2019
2
COVIDIEN LLC
II
Jul-09-2019
3
Covidien LP
I
Aug-11-2023
4
Covidien LP
I
Jan-12-2023
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