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TPLC
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show TPLC since
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Device
filter, infusion line
Regulation Description
Intravascular administration set.
Product Code
FPB
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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