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TPLC
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show TPLC since
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2024
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Device
system, transport, aerobic
Product Code
JTW
Regulation Number
866.2900
Device Class
1
Premarket Reviews
Manufacturer
Decision
COPAN FLOCK TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
2
2
2016
2
2
2017
14
14
2018
32
32
2019
8
8
2020
12
12
2021
7
7
2022
5
5
2023
23
23
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
28
28
Short Fill
16
16
Device Contamination with Chemical or Other Material
14
14
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Fluid/Blood Leak
8
8
Volume Accuracy Problem
6
6
Device Markings/Labelling Problem
6
6
Delivered as Unsterile Product
4
4
Break
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Material Protrusion/Extrusion
3
3
Detachment of Device or Device Component
3
3
Device Ingredient or Reagent Problem
3
3
Product Quality Problem
3
3
Component Missing
3
3
Device Operates Differently Than Expected
2
2
Difficult to Open or Close
2
2
No Apparent Adverse Event
2
2
Separation Problem
2
2
Premature Separation
1
1
Missing Information
1
1
Insufficient Information
1
1
Scratched Material
1
1
Naturally Worn
1
1
Failure to Shut Off
1
1
Incorrect Or Inadequate Test Results
1
1
Use of Device Problem
1
1
Difficult to Remove
1
1
Material Separation
1
1
Detachment Of Device Component
1
1
Contamination
1
1
Premature Activation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
49
49
No Clinical Signs, Symptoms or Conditions
47
47
No Consequences Or Impact To Patient
14
14
No Patient Involvement
3
3
No Information
2
2
No Code Available
1
1
Reaction
1
1
Needle Stick/Puncture
1
1
Blood Loss
1
1
Hemorrhage/Bleeding
1
1
Hypersensitivity/Allergic reaction
1
1
Failure of Implant
1
1
Inflammation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Company
II
Nov-21-2018
2
Becton Dickinson & Company
III
Mar-08-2010
3
Hologic, Inc
II
Mar-11-2022
4
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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