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TPLC
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Device
dispenser, liquid medication
Product Code
KYX
Regulation Number
880.6430
Device Class
1
Premarket Reviews
Manufacturer
Decision
KLEENGEL, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
9
9
2016
9
9
2017
17
17
2018
17
17
2019
17
27
2020
33
33
2021
7
7
2022
11
11
2023
31
31
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
28
38
Device Markings/Labelling Problem
23
23
Fluid/Blood Leak
16
16
Break
12
12
Leak/Splash
12
12
Contamination /Decontamination Problem
12
12
Unsealed Device Packaging
10
10
Adverse Event Without Identified Device or Use Problem
5
5
Illegible Information
5
5
Application Program Problem: Medication Error
3
3
Packaging Problem
3
3
Component Missing
3
3
Patient-Device Incompatibility
3
3
Device Contaminated During Manufacture or Shipping
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Device Damaged Prior to Use
2
2
Device Operates Differently Than Expected
2
2
Failure to Deliver
2
2
Defective Device
2
2
Malposition of Device
2
2
Mechanical Problem
2
2
Particulates
2
2
Product Quality Problem
2
2
Contamination
2
2
Protective Measures Problem
2
2
Scratched Material
1
1
Appropriate Term/Code Not Available
1
1
Positioning Problem
1
1
Device Fell
1
1
Missing Information
1
1
Device Contaminated at the User Facility
1
1
Crack
1
1
Material Discolored
1
1
Difficult to Fold, Unfold or Collapse
1
1
Excess Flow or Over-Infusion
1
1
Complete Blockage
1
1
Component(s), broken
1
1
Detachment Of Device Component
1
1
Component Falling
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
Inaccurate Delivery
1
1
Obstruction of Flow
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Detachment of Device or Device Component
1
1
Device Packaging Compromised
1
1
Mechanical Jam
1
1
No Fail-Safe Mechanism
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
52
52
No Clinical Signs, Symptoms or Conditions
44
44
No Patient Involvement
31
41
Insufficient Information
14
14
No Consequences Or Impact To Patient
11
11
No Information
3
3
Eye Infections
2
2
Reaction
2
2
Anaphylactoid
1
1
Foreign body, removal of
1
1
Aspiration/Inhalation
1
1
Dyspnea
1
1
Edema
1
1
Hypersensitivity/Allergic reaction
1
1
Itching Sensation
1
1
Pain
1
1
Rash
1
1
No Code Available
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Corporation Englewood
II
Feb-27-2015
2
Baxter Corporation Englewood
II
Dec-24-2014
3
Baxter Healthcare Corporation
II
Apr-20-2023
4
Baxter Healthcare Corporation
II
Aug-25-2022
5
Baxter Healthcare Corporation
II
Apr-15-2022
6
Baxter Healthcare Corporation
III
Aug-29-2019
7
Becton Dickinson & Company
III
Feb-23-2012
8
Benlan, Inc.
III
Feb-21-2012
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