Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
container, specimen mailer and storage, sterile
Product Code
KDT
Regulation Number
864.3250
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
70
70
2019
51
51
2020
21
21
2021
27
27
2022
39
39
2023
23
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
52
52
Short Fill
34
34
Device Contamination with Chemical or Other Material
33
33
Incorrect, Inadequate or Imprecise Result or Readings
18
18
Device Markings/Labelling Problem
16
16
Incorrect Or Inadequate Test Results
15
15
Material Protrusion/Extrusion
13
13
Missing Information
13
13
Product Quality Problem
12
12
Volume Accuracy Problem
12
12
Material Deformation
9
9
Fluid/Blood Leak
8
8
Delivered as Unsterile Product
7
7
Break
5
5
Physical Resistance/Sticking
4
4
Component Missing
3
3
Material Discolored
3
3
Difficult to Insert
2
2
Shielding Failure
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
Complete Blockage
1
1
Component Incompatible
1
1
Fracture
1
1
Unsealed Device Packaging
1
1
Material Puncture/Hole
1
1
Overfill
1
1
Deformation Due to Compressive Stress
1
1
Contamination /Decontamination Problem
1
1
Detachment of Device or Device Component
1
1
Separation Problem
1
1
Inaccurate Information
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Protective Measures Problem
1
1
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
102
102
No Clinical Signs, Symptoms or Conditions
75
75
No Consequences Or Impact To Patient
19
19
Needle Stick/Puncture
17
17
No Information
8
8
No Patient Involvement
5
5
Exposure to Body Fluids
2
2
Laceration(s)
1
1
Pain
1
1
Injury
1
1
No Code Available
1
1
Blood Loss
1
1
-
-