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TPLC
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show TPLC since
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Device
container, specimen mailer and storage, sterile
Product Code
KDT
Regulation Number
864.3250
Device Class
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2017
42
42
2018
70
70
2019
51
51
2020
21
21
2021
27
27
2022
39
39
2023
25
25
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
56
56
Device Contamination with Chemical or Other Material
45
45
Short Fill
34
34
Device Markings/Labelling Problem
21
21
Incorrect, Inadequate or Imprecise Result or Readings
18
18
Incorrect Or Inadequate Test Results
15
15
Product Quality Problem
13
13
Missing Information
13
13
Material Protrusion/Extrusion
13
13
Fluid/Blood Leak
12
12
Volume Accuracy Problem
12
12
Material Deformation
9
9
Delivered as Unsterile Product
9
9
Component Missing
7
7
Adverse Event Without Identified Device or Use Problem
6
6
Break
5
5
Material Discolored
4
4
Physical Resistance/Sticking
4
4
Mushroomed
2
2
Difficult to Insert
2
2
Contamination of Device Ingredient or Reagent
2
2
Detachment of Device or Device Component
2
2
Out-Of-Box Failure
1
1
Overfill
1
1
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Structural Problem
1
1
Deformation Due to Compressive Stress
1
1
Contamination /Decontamination Problem
1
1
Shielding Failure
1
1
Unsealed Device Packaging
1
1
Material Puncture/Hole
1
1
Entrapment of Device
1
1
Filling Problem
1
1
Fracture
1
1
Hole In Material
1
1
Complete Blockage
1
1
Detachment Of Device Component
1
1
Component Incompatible
1
1
Contamination
1
1
Crack
1
1
Protective Measures Problem
1
1
Insufficient Information
1
1
Separation Problem
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
129
129
No Clinical Signs, Symptoms or Conditions
78
78
No Consequences Or Impact To Patient
26
26
Needle Stick/Puncture
25
25
No Information
9
9
No Patient Involvement
5
5
Exposure to Body Fluids
3
3
Laceration(s)
1
1
Pain
1
1
Injury
1
1
No Code Available
1
1
Blood Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Heritage Labs International LLC
II
Jan-11-2012
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