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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 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 77 77
Material Deformation 42 42
Material Frayed 40 40
Adverse Event Without Identified Device or Use Problem 39 39
Obstruction of Flow 27 27
Break 25 25
Defective Component 22 22
Material Puncture/Hole 21 21
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 9 9
Component Incompatible 8 8
Leak/Splash 7 7
Unraveled Material 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
Insufficient Flow or Under Infusion 4 4
Difficult to Insert 4 4
Collapse 3 3
Disconnection 3 3
Migration or Expulsion of Device 3 3
Suction Problem 3 3
Failure to Advance 3 3
Difficult to Advance 3 3
Infusion or Flow Problem 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
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
Defective Device 1 1
Device Displays Incorrect Message 1 1
Structural Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Device Slipped 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 182 182
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
Fatigue 1 1
Encephalopathy 1 1
Abdominal Pain 1 1
Arrhythmia 1 1
Hemothorax 1 1
Laceration(s) 1 1
Thrombus 1 1
Injury 1 1
Obstruction/Occlusion 1 1
Cardiac Perforation 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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