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
dispenser, liquid medication
Product Code
KYX
Regulation Number
880.6430
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
17
17
2019
17
27
2020
33
33
2021
7
7
2022
11
11
2023
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
20
30
Device Markings/Labelling Problem
18
18
Contamination /Decontamination Problem
11
11
Leak/Splash
10
10
Unsealed Device Packaging
10
10
Fluid/Blood Leak
8
8
Break
7
7
Illegible Information
4
4
Component Missing
3
3
Device Contaminated During Manufacture or Shipping
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Failure to Deliver
2
2
Product Quality Problem
2
2
Device Damaged Prior to Use
2
2
Malposition of Device
2
2
Application Program Problem: Medication Error
2
2
Device Fell
1
1
Missing Information
1
1
Device Contaminated at the User Facility
1
1
Use of Device Problem
1
1
Volume Accuracy Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Fungus in Device Environment
1
1
Particulates
1
1
Complete Blockage
1
1
Contamination
1
1
Material Discolored
1
1
Difficult to Fold, Unfold or Collapse
1
1
Mechanical Problem
1
1
Inaccurate Delivery
1
1
Obstruction of Flow
1
1
Defective Device
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Detachment of Device or Device Component
1
1
Positioning Problem
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
No Fail-Safe Mechanism
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
32
32
No Known Impact Or Consequence To Patient
31
31
No Patient Involvement
23
33
Insufficient Information
11
11
No Consequences Or Impact To Patient
11
11
Eye Infections
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Aspiration/Inhalation
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Apr-20-2023
2
Baxter Healthcare Corporation
II
Aug-25-2022
3
Baxter Healthcare Corporation
II
Apr-15-2022
4
Baxter Healthcare Corporation
III
Aug-29-2019
-
-