TPLC - Total Product Life Cycle

• 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
2021	7	7
2022	11	12
2023	31	31
2024	20	20
2025	11	11
2026	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Contamination /Decontamination Problem	10	10
Device Markings/Labelling Problem	8	8
Contamination	5	5
Device Contamination with Chemical or Other Material	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Break	2	2
Illegible Information	2	3
Fluid/Blood Leak	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Contamination of Device Ingredient or Reagent	1	1
Material Discolored	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Incorrect Measurement	1	1
Leak/Splash	1	1
Patient-Device Incompatibility	1	1
Crack	1	1
Particulates	1	1
Insufficient Device Problem Information	1	1
Missing Information	1	1
Infusion or Flow 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	65	66
Insufficient Information	17	17
Eye Infections	2	2
Chemical Exposure	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Airway Obstruction	1	1
Diarrhea	1	1
Headache	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