TPLC - Total Product Life Cycle

• Device: system, blood collection, vacuum-assisted, manual
• Product Code: KST
• Regulation Number: 864.9125
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	15	15
2016	10	10
2017	1	1
2018	7	7
2019	5	5
2020	2	2
2022	1	1
2023	8	8
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	10	10
Material Separation	10	10
Leak/Splash	8	8
Crack	7	7
Detachment of Device or Device Component	4	4
Mechanical Problem	3	3
Break	3	3
Appropriate Term/Code Not Available	3	3
Defective Device	2	2
Detachment Of Device Component	2	2
Nonstandard Device	2	2
Gas/Air Leak	2	2
Material Integrity Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Dislodged or Dislocated	1	1
Product Quality Problem	1	1
Device Slipped	1	1
Bent	1	1
Loose or Intermittent Connection	1	1
Difficult to Insert	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	25	25
Blood Loss	5	5
No Clinical Signs, Symptoms or Conditions	5	5
No Consequences Or Impact To Patient	4	4
Exposure to Body Fluids	4	4
Hemorrhage/Bleeding	3	3
No Information	3	3
Inflammation	2	2
Blurred Vision	1	1
Hypersensitivity/Allergic reaction	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Patient Involvement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	Aug-16-2011
2	Heritage Labs International LLC	II	Apr-18-2013
3	Hummingbird Med	I	Jul-05-2016
4	Hummingbird Med	I	May-20-2016