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TPLC
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show TPLC since
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2024
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Device
tubing, fluid delivery
Product Code
FPK
Regulation Number
880.5440
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
15
15
2018
9
9
2019
10
10
2020
4
4
2021
8
8
2022
7
7
2023
15
15
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
21
21
Defective Component
11
11
Fluid/Blood Leak
11
11
No Flow
10
10
Suction Failure
8
8
Break
6
6
Disconnection
5
5
Detachment of Device or Device Component
5
5
Device Contamination with Chemical or Other Material
4
4
Crack
3
3
Defective Device
3
3
No Apparent Adverse Event
3
3
Device Operates Differently Than Expected
3
3
Loose or Intermittent Connection
3
3
Split
2
2
Material Disintegration
2
2
Complete Blockage
2
2
Insufficient Information
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Particulates
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Physical Resistance
1
1
Physical Resistance/Sticking
1
1
Accessory Incompatible
1
1
Restricted Flow rate
1
1
Unintended Movement
1
1
Difficult to Flush
1
1
Suction Problem
1
1
Device Slipped
1
1
Material Split, Cut or Torn
1
1
Failure to Deliver
1
1
Use of Device Problem
1
1
Material Separation
1
1
Free or Unrestricted Flow
1
1
Improper or Incorrect Procedure or Method
1
1
Component Falling
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
28
28
No Consequences Or Impact To Patient
17
17
No Known Impact Or Consequence To Patient
12
12
Insufficient Information
8
8
Blood Loss
4
4
No Information
3
3
Hemorrhage/Bleeding
3
3
Chemical Exposure
2
2
Exposure to Body Fluids
1
1
No Patient Involvement
1
1
Therapeutic Response, Decreased
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hospira Inc.
II
Jan-11-2017
2
Medtronic Inc.
II
Nov-18-2017
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