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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
Regulation Description Blood access device and accessories.
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

MDR Year MDR Reports MDR Events
2020 51 51
2021 61 61
2022 119 119
2023 103 103
2024 125 125
2025 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 95 95
Material Deformation 58 58
Obstruction of Flow 47 47
Adverse Event Without Identified Device or Use Problem 43 43
Material Frayed 40 40
Break 33 33
Defective Component 26 26
Material Puncture/Hole 23 23
Detachment of Device or Device Component 18 18
Difficult to Remove 15 15
Device Dislodged or Dislocated 14 14
Unraveled Material 14 14
Material Twisted/Bent 11 11
Component Incompatible 9 9
Failure to Infuse 9 9
Product Quality Problem 9 9
Material Fragmentation 8 8
Insufficient Information 6 6
Insufficient Flow or Under Infusion 6 6
Contamination /Decontamination Problem 6 6
Physical Resistance/Sticking 5 5
Suction Problem 4 4
Material Separation 3 3
Collapse 3 3
Difficult to Advance 3 3
Infusion or Flow Problem 3 3
Difficult to Insert 3 3
Material Too Rigid or Stiff 3 3
Nonstandard Device 2 2
Failure to Advance 2 2
Gas/Air Leak 2 2
Material Integrity Problem 2 2
Migration or Expulsion of Device 2 2
Leak/Splash 2 2
Disconnection 2 2
Device Difficult to Setup or Prepare 1 1
Backflow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Structural Problem 1 1
Defective Device 1 1
Filling Problem 1 1
Misassembled 1 1
Device Markings/Labelling Problem 1 1
Restricted Flow rate 1 1
Crack 1 1
Activation Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Migration 1 1
Fracture 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 280 280
Insufficient Information 70 70
Swelling/ Edema 48 48
Erythema 47 47
No Consequences Or Impact To Patient 46 46
Hemorrhage/Bleeding 21 21
Foreign Body In Patient 17 17
Unintended Radiation Exposure 5 5
Hematoma 3 3
Great Vessel Perforation 3 3
Skin Inflammation/ Irritation 2 2
Exsanguination 2 2
Needle Stick/Puncture 2 2
Laceration(s) 2 2
Perforation of Vessels 2 2
Abdominal Pain 1 1
Air Embolism 1 1
Encephalopathy 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Fatigue 1 1
Radiation Exposure, Unintended 1 1
Anaphylactoid 1 1
Obstruction/Occlusion 1 1
Cardiac Arrest 1 1
Cardiac Tamponade 1 1
No Known Impact Or Consequence To Patient 1 1
Burning Sensation 1 1
Injury 1 1
Chest Pain 1 1
Renal Impairment 1 1
Hypoxia 1 1
Loss of consciousness 1 1
Hemothorax 1 1
Aspiration Pneumonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP I Aug-11-2023
2 Covidien LP I Jan-12-2023
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