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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intravenous extension tubing set
Regulation Description Intravascular administration set.
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOJA
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2019 4 4
2020 9 9
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 3 3
Fluid Leak 2 2
Packaging Problem 2 2
Disconnection 2 2
Leak/Splash 2 2
Tear, Rip or Hole in Device Packaging 2 2
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Excess Flow or Over-Infusion 1 1
Gas Leak 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 5 5
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 3 3
Insufficient Information 3 3

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