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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
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 6 6
Leak/Splash 3 3
Flushing Problem 2 2
Gas/Air Leak 2 2
Disconnection 2 2
Fluid/Blood Leak 2 2
Device Contamination with Chemical or Other Material 1 1
Crack 1 1
Excess Flow or Over-Infusion 1 1
Blocked Connection 1 1
Tear, Rip or Hole in Device Packaging 1 1
Packaging Problem 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 4 4
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Air Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Aug-12-2024
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