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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNIE
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
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 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 82 82
Material Deformation 48 48
Material Frayed 40 40
Adverse Event Without Identified Device or Use Problem 39 39
Obstruction of Flow 32 32
Break 27 27
Defective Component 22 22
Material Puncture/Hole 22 22
Difficult to Remove 18 18
Detachment of Device or Device Component 18 18
Device Dislodged or Dislocated 16 16
Material Twisted/Bent 10 10
Product Quality Problem 10 10
Failure to Infuse 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
Material Integrity Problem 5 5
Gas/Air Leak 5 5
Suction Problem 4 4
Insufficient Flow or Under Infusion 4 4
Difficult to Insert 4 4
Migration or Expulsion of Device 3 3
Disconnection 3 3
Collapse 3 3
Material Too Rigid or Stiff 3 3
Infusion or Flow Problem 3 3
Difficult to Advance 3 3
Failure to Advance 3 3
Material Split, Cut or Torn 3 3
Malposition of Device 2 2
Deformation Due to Compressive Stress 2 2
Device Markings/Labelling Problem 2 2
Contamination of Device Ingredient or Reagent 1 1
Activation, Positioning or Separation Problem 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Material Protrusion/Extrusion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Activation Problem 1 1
Noise, Audible 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Rupture 1 1
Device Slipped 1 1
Device Difficult to Setup or Prepare 1 1
Improper or Incorrect Procedure or Method 1 1
Structural Problem 1 1
Device Alarm System 1 1
Backflow 1 1
Entrapment of Device 1 1
Crack 1 1
Deflation Problem 1 1
Mechanical Problem 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 203 203
No Consequences Or Impact To Patient 58 58
Insufficient Information 55 55
Swelling/ Edema 48 48
Erythema 47 47
No Known Impact Or Consequence To Patient 30 30
Hemorrhage/Bleeding 12 12
Foreign Body In Patient 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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