Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device dispenser, liquid medication
Regulation Description Liquid medication dispenser.
Product CodeKYX
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
-
-