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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intravenous catheter force-activated separation device.
Regulation Description Intravenous catheter force-activated separation device.
Definition An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.
Product CodeQOI
Regulation Number 880.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
LINEAR HEALTH SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 4
LINEUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
LINEUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SITE SAVER, INC. D/B/A LINEUS MEDICAL
  GRANTED 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1
2024 1 1
2025 64 64
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fail-Safe Problem 53 53
Leak/Splash 11 11
Detachment of Device or Device Component 7 7
Complete Blockage 1 1
Material Twisted/Bent 1 1
Partial Blockage 1 1
Material Separation 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
Diabetic Ketoacidosis 1 1
Needle Stick/Puncture 1 1
Foreign Body Embolism 1 1
Insufficient Information 1 1
Hyperglycemia 1 1
Unspecified Vascular Problem 1 1

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