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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
container, specimen mailer and storage, sterile
Regulation Description
Specimen transport and storage container.
Product Code
KDT
Regulation Number
864.3250
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
21
21
2021
27
27
2022
39
39
2023
25
25
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
18
18
Short Fill
14
14
Missing Information
13
13
Device Markings/Labelling Problem
11
11
Device Contamination with Chemical or Other Material
10
10
Volume Accuracy Problem
9
9
Product Quality Problem
8
8
Fluid/Blood Leak
8
8
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Delivered as Unsterile Product
6
6
Material Protrusion/Extrusion
6
6
Break
4
4
Physical Resistance/Sticking
4
4
Component Missing
3
3
Material Discolored
3
3
Material Deformation
3
3
Difficult to Insert
1
1
Unsealed Device Packaging
1
1
Material Puncture/Hole
1
1
Shielding Failure
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Complete Blockage
1
1
Fracture
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Protective Measures Problem
1
1
Separation Problem
1
1
Inaccurate Information
1
1
Deformation Due to Compressive Stress
1
1
Detachment of Device or Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
84
84
Needle Stick/Puncture
11
11
No Known Impact Or Consequence To Patient
10
10
No Consequences Or Impact To Patient
8
8
No Patient Involvement
4
4
Exposure to Body Fluids
1
1
Pain
1
1
-
-