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
EPIC MEDICAL PTE 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	114	114

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	284	322
Device Contamination with Chemical or Other Material	251	279
Contamination /Decontamination Problem	156	156
Break	41	41
Leak/Splash	36	36
Disconnection	32	32
Detachment of Device or Device Component	21	21
Material Puncture/Hole	14	14
Particulates	10	10
Contamination	10	10
Crack	9	9
Degraded	9	9
Material Split, Cut or Torn	8	8
Material Rupture	7	7
Mechanical Problem	6	6
Difficult to Open or Close	6	6
Device Dislodged or Dislocated	6	6
Material Separation	5	5
Defective Component	4	4
Component Missing	4	4
Contamination of Device Ingredient or Reagent	4	4
Component Misassembled	4	4
Failure to Disconnect	3	4
Defective Device	3	3
No Flow	3	3
Tear, Rip or Hole in Device Packaging	3	3
Cut In Material	3	3
Material Perforation	3	3
Loose or Intermittent Connection	3	3
Fracture	3	3
Hole In Material	2	2
Microbial Contamination of Device	2	2
Device Slipped	2	2
Product Quality Problem	2	2
Device Difficult to Setup or Prepare	2	2
Decrease in Pressure	2	2
Improper Flow or Infusion	2	2
Unexpected Color	2	2
Device Fell	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Integrity Problem	2	2
Scratched Material	2	2
Material Deformation	1	1
Priming Problem	1	1
Separation Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Free or Unrestricted Flow	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Pressure Problem	1	1
Pumping Problem	1	1
Application Program Problem	1	1
Fail-Safe Problem	1	1
Device Markings/Labelling Problem	1	1
Precipitate in Device or Device Ingredient	1	1
Premature Activation	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Device Damaged Prior to Use	1	1
Failure to Advance	1	1
Obstruction of Flow	1	1
Labelling, Instructions for Use or Training Problem	1	1
Burst Container or Vessel	1	1
Entrapment of Device	1	1
Filling Problem	1	1
Misassembled	1	1
Misconnection	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	380	434
No Clinical Signs, Symptoms or Conditions	368	368
No Consequences Or Impact To Patient	48	56
No Known Impact Or Consequence To Patient	43	48
Insufficient Information	30	30
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