TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EPIC MEDICAL PTE 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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	249	277
Device Contamination with Chemical or Other Material	213	236
Contamination /Decontamination Problem	157	157
Leak/Splash	33	33
Break	33	33
Detachment of Device or Device Component	31	31
Disconnection	28	28
Material Puncture/Hole	16	16
Mechanical Problem	11	11
Contamination	10	10
Material Split, Cut or Torn	9	9
Crack	9	9
Particulates	9	9
Material Rupture	8	8
Degraded	8	8
Material Separation	7	7
Air/Gas in Device	7	7
Device Dislodged or Dislocated	6	6
Difficult to Open or Close	5	5
Component Misassembled	4	4
Contamination of Device Ingredient or Reagent	4	4
Defective Component	4	4
No Flow	3	3
Fracture	3	3
Tear, Rip or Hole in Device Packaging	3	3
Component Missing	3	3
Defective Device	3	3
Microbial Contamination of Device	2	2
Scratched Material	2	2
Device Difficult to Setup or Prepare	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Improper Flow or Infusion	2	2
Decrease in Pressure	2	2
Unexpected Color	2	2
Product Quality Problem	2	2
Failure to Disconnect	2	3
Device Slipped	2	2
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Integrity Problem	1	1
Fail-Safe Problem	1	1
Precipitate in Device or Device Ingredient	1	1
Obstruction of Flow	1	1
Material Perforation	1	1
Infusion or Flow Problem	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Material Deformation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Fell	1	1
Filling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	467	467
No Patient Involvement	264	303
Insufficient Information	43	43
No Consequences Or Impact To Patient	37	45
No Known Impact Or Consequence To Patient	35	40
Air Embolism	2	2
No Information	2	2
Hypoxia	2	2
Chemical Exposure	1	1
Exposure to Body Fluids	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
2	Microtek Medical Inc.	II	Aug-16-2024
3	ROi CPS LLC	II	Aug-16-2024
4	Stradis Healthcare	II	Jan-11-2023
5	The Metrix Company	II	Oct-01-2019