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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dispenser, liquid medication
Product CodeKYX
Regulation Number 880.6430
Device Class 1


Premarket Reviews
ManufacturerDecision
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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 27 37
Device Markings/Labelling Problem 23 23
Fluid/Blood Leak 15 15
Leak/Splash 12 12
Contamination /Decontamination Problem 12 12
Break 11 11
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 40 40
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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