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TPLC
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show TPLC since
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Device
system, blood collection, vacuum-assisted, manual
Product Code
KST
Regulation Number
864.9125
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
15
15
2016
10
10
2017
1
1
2018
7
7
2019
5
5
2020
2
2
2022
1
1
2023
8
8
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
10
10
Fluid/Blood Leak
10
10
Leak/Splash
8
8
Crack
7
7
Detachment of Device or Device Component
4
4
Break
3
3
Mechanical Problem
3
3
Appropriate Term/Code Not Available
3
3
Defective Device
2
2
Nonstandard Device
2
2
Gas/Air Leak
2
2
Detachment Of Device Component
2
2
Patient Device Interaction Problem
1
1
Difficult to Insert
1
1
Bent
1
1
Device Slipped
1
1
Insufficient Information
1
1
Material Integrity Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Product Quality Problem
1
1
Loose or Intermittent Connection
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
25
25
No Clinical Signs, Symptoms or Conditions
6
6
Blood Loss
5
5
Exposure to Body Fluids
4
4
No Consequences Or Impact To Patient
4
4
No Information
3
3
Hemorrhage/Bleeding
3
3
Inflammation
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hypersensitivity/Allergic reaction
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Blurred Vision
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Company
II
Aug-16-2011
2
Heritage Labs International LLC
II
Apr-18-2013
3
Hummingbird Med
I
Jul-05-2016
4
Hummingbird Med
I
May-20-2016
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