TPLC - Total Product Life Cycle

• Device: container, i.v.
• Product Code: KPE
• Regulation Number: 880.5025
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GILERO, LLC
	SUBSTANTIALLY EQUIVALENT	1
HAEMOTRONIC S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
HAEMOTRONIC, SPA
	SUBSTANTIALLY EQUIVALENT	1
HEALTH CARE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VALMED SRL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	142	157
2019	204	256
2020	147	147
2021	161	161
2022	112	112
2023	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	243	281
Device Contamination with Chemical or Other Material	231	259
Contamination /Decontamination Problem	152	152
Break	39	39
Leak/Splash	30	30
Disconnection	28	28
Detachment of Device or Device Component	12	12
Degraded	9	9
Material Split, Cut or Torn	8	8
Contamination	8	8
Material Puncture/Hole	8	8
Material Rupture	7	7
Crack	7	7
Particulates	6	6
Difficult to Open or Close	6	6
Device Dislodged or Dislocated	6	6
Mechanical Problem	5	5
Component Missing	4	4
Tear, Rip or Hole in Device Packaging	3	3
Defective Component	3	3
Cut In Material	3	3
Failure to Disconnect	3	4
Defective Device	3	3
Material Separation	3	3
Material Perforation	3	3
Loose or Intermittent Connection	3	3
Fracture	3	3
Component Misassembled	3	3
Unexpected Color	2	2
Improper Flow or Infusion	2	2
Device Fell	2	2
Scratched Material	2	2
Material Integrity Problem	2	2
Hole In Material	2	2
Device Slipped	2	2
Product Quality Problem	2	2
Device Difficult to Setup or Prepare	2	2
Decrease in Pressure	2	2
Microbial Contamination of Device	2	2
Obstruction of Flow	1	1
Application Program Problem	1	1
Failure to Advance	1	1
Device Damaged Prior to Use	1	1
Entrapment of Device	1	1
Filling Problem	1	1
Burst Container or Vessel	1	1
Precipitate in Device or Device Ingredient	1	1
Premature Activation	1	1
Misassembled	1	1
Misconnection	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
No Flow	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Pressure Problem	1	1
Pumping Problem	1	1
Separation Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Fail-Safe Problem	1	1
Device Markings/Labelling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	380	434
No Clinical Signs, Symptoms or Conditions	274	274
No Consequences Or Impact To Patient	48	56
No Known Impact Or Consequence To Patient	43	48
Insufficient Information	27	27
No Information	9	9
Air Embolism	2	2
Hypoxia	2	2
Sprain	1	1
Exposure to Body Fluids	1	1
Chemical Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Nov-02-2018
2	Baxter Healthcare Corporation	II	Jan-11-2018
3	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
4	Stradis Healthcare	II	Jan-11-2023
5	The Metrix Company	II	Oct-01-2019