TPLC - Total Product Life Cycle

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Device	dispenser, liquid medication
Regulation Description	Liquid medication dispenser.
Product Code	KYX
Regulation Number	880.6430
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Markings/Labelling Problem	9	9
Contamination /Decontamination Problem	9	9
Unsealed Device Packaging	8	8
Fluid/Blood Leak	6	6
Break	5	5
Contamination	5	5
Device Contamination with Chemical or Other Material	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Fitting Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Malposition of Device	2	2
Defective Device	2	2
Application Program Problem: Medication Error	2	2
Particulates	2	2
Contamination of Device Ingredient or Reagent	2	2
Illegible Information	2	3
Appropriate Term/Code Not Available	2	2
Leak/Splash	1	1
Mechanical Problem	1	1
Crack	1	1
Complete Blockage	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
No Fail-Safe Mechanism	1	1
Failure to Deliver	1	1
Scratched Material	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Component Missing	1	1
Infusion or Flow Problem	1	1
Incorrect Measurement	1	1
Product Quality Problem	1	1
Missing Information	1	1
Inaccurate Delivery	1	1
Connection Problem	1	1
Corroded	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	59	60
Insufficient Information	17	17
Eye Infections	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Airway Obstruction	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