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	250	278
Device Contamination with Chemical or Other Material	219	242
Contamination /Decontamination Problem	158	158
Leak/Splash	34	34
Break	33	33
Detachment of Device or Device Component	33	33
Disconnection	29	29
Material Puncture/Hole	16	16
Mechanical Problem	11	11
Particulates	10	10
Contamination	10	10
Crack	9	9
Material Split, Cut or Torn	9	9
Degraded	8	8
Material Rupture	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
Defective Component	4	4
Contamination of Device Ingredient or Reagent	4	4
Defective Device	3	3
Component Missing	3	3
Tear, Rip or Hole in Device Packaging	3	3
Fracture	3	3
No Flow	3	3
Improper Flow or Infusion	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Failure to Disconnect	2	3
Scratched Material	2	2
Unexpected Color	2	2
Device Difficult to Setup or Prepare	2	2
Decrease in Pressure	2	2
Microbial Contamination of Device	2	2
Product Quality Problem	2	2
Device Slipped	2	2
Material Perforation	1	1
Device Damaged Prior to Use	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Obstruction of Flow	1	1
Failure to Advance	1	1
Application Program Problem	1	1
Precipitate in Device or Device Ingredient	1	1
Premature Activation	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Loose or Intermittent Connection	1	1
Labelling, Instructions for Use or Training Problem	1	1
Entrapment of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	478	478
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
Chemical Exposure	2	2
Hypoxia	2	2
Exposure to Body Fluids	1	1
Awareness during Anaesthesia	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