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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
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
2019 4 4
2020 9 9
2021 6 6
2022 3 3
2023 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 7 7
Leak/Splash 3 3
Gas/Air Leak 2 2
Packaging Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Disconnection 2 2
Fluid/Blood Leak 2 2
Flushing Problem 2 2
Excess Flow or Over-Infusion 1 1
Obstruction of Flow 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
No Patient Involvement 5 5
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
Air Embolism 1 1

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