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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, infusion line
Regulation Description Intravascular administration set.
Product CodeFPB
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 18 18
2021 160 160
2022 36 36
2023 39 39
2024 47 47
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 227 227
Crack 37 37
Disconnection 15 15
Leak/Splash 10 10
Break 10 10
Obstruction of Flow 8 8
No Flow 8 8
Material Puncture/Hole 7 7
Defective Component 5 5
Backflow 5 5
Complete Blockage 4 4
Material Separation 3 3
Pressure Problem 2 2
Difficult to Flush 2 2
Material Discolored 2 2
Improper Flow or Infusion 2 2
Insufficient Flow or Under Infusion 2 2
Device Contamination with Chemical or Other Material 2 2
Fracture 2 2
Increase in Pressure 2 2
Protective Measures Problem 2 2
Restricted Flow rate 1 1
Filtration Problem 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Air/Gas in Device 1 1
Gas/Air Leak 1 1
Audible Prompt/Feedback Problem 1 1
Failure to Prime 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Connection Problem 1 1
Priming Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 238 238
No Consequences Or Impact To Patient 51 51
Insufficient Information 21 21
No Known Impact Or Consequence To Patient 5 5
Low Blood Pressure/ Hypotension 3 3
High Blood Pressure/ Hypertension 2 2
No Patient Involvement 2 2
Fever 1 1
Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Apr-21-2021
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