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
dispenser, liquid medication
Regulation Description
Liquid medication dispenser.
Product Code
KYX
Regulation Number
880.6430
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
33
33
2021
7
7
2022
11
11
2023
31
31
2024
20
20
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Markings/Labelling Problem
18
18
Contamination /Decontamination Problem
11
11
Device Contamination with Chemical or Other Material
10
10
Unsealed Device Packaging
8
8
Leak/Splash
7
7
Break
6
6
Fluid/Blood Leak
6
6
Illegible Information
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Device Contaminated During Manufacture or Shipping
3
3
Malposition of Device
2
2
Device Damaged Prior to Use
2
2
Contamination
2
2
Failure to Deliver
2
2
Component Missing
2
2
Application Program Problem: Medication Error
2
2
Product Quality Problem
2
2
Appropriate Term/Code Not Available
2
2
Fitting Problem
1
1
Mechanical Problem
1
1
Volume Accuracy Problem
1
1
Crack
1
1
Complete Blockage
1
1
Difficult to Fold, Unfold or Collapse
1
1
Patient-Device Incompatibility
1
1
Defective Device
1
1
No Fail-Safe Mechanism
1
1
Scratched Material
1
1
Material Discolored
1
1
Use of Device Problem
1
1
Particulates
1
1
Contamination of Device Ingredient or Reagent
1
1
Missing Information
1
1
Inaccurate Delivery
1
1
Fungus in Device Environment
1
1
Connection Problem
1
1
Device Contaminated at the User Facility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
52
52
No Known Impact Or Consequence To Patient
18
18
Insufficient Information
14
14
No Patient Involvement
11
11
No Consequences Or Impact To Patient
4
4
Eye Infections
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Avanos Medical, Inc.
III
Jun-07-2024
2
Baxter Healthcare Corporation
II
Apr-20-2023
3
Baxter Healthcare Corporation
II
Aug-25-2022
4
Baxter Healthcare Corporation
II
Apr-15-2022
-
-