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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device administrations sets with neuraxial connectors
Regulation Description Intravascular administration set.
Definition The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Product CodePWH
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 5 5
2022 17 17
2023 2 2
2024 16 16
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 24 24
Leak/Splash 8 8
Break 8 8
Insufficient Flow or Under Infusion 6 6
Obstruction of Flow 2 2
Connection Problem 2 2
Disconnection 1 1
Complete Blockage 1 1
Separation Failure 1 1
Air/Gas in Device 1 1
Inaccurate Flow Rate 1 1
Blocked Connection 1 1
Infusion or Flow Problem 1 1
Failure to Prime 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 6 6
Insufficient Information 1 1

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