TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BERPU MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH200, LLC
	SUBSTANTIALLY EQUIVALENT	1
GEMTIER MEDICAL (SHANGHAI), INC.
	SUBSTANTIALLY EQUIVALENT	1
HENAN NURSECARE BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JEESUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
METHYL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RONCADELLE OPERATIONS SRL
	SUBSTANTIALLY EQUIVALENT	1
SHANTOU WEALY MEDICAL INSTRUMENT CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
SHINA MED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU SAVICRED BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VAULT PARAGON GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG LINGYANG MEDICAL APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	210	212
Break	124	145
Retraction Problem	119	149
Difficult or Delayed Activation	67	67
Fail-Safe Problem	66	80
Detachment of Device or Device Component	58	79
Device Contaminated During Manufacture or Shipping	47	47
Activation Failure	47	47
Fluid/Blood Leak	46	64
Defective Component	44	45
Activation Problem	39	39
Material Twisted/Bent	29	60
Device Contamination with Chemical or Other Material	28	28
Defective Device	25	29
Malposition of Device	18	18
Material Separation	17	34
Premature Activation	16	16
Device Markings/Labelling Problem	15	15
Contamination	15	15
Decoupling	12	12
Volume Accuracy Problem	12	12
Material Deformation	12	12
Failure to Deliver	11	11
Mechanical Problem	10	10
Material Protrusion/Extrusion	9	10
Positioning Failure	9	9
Fail-Safe Did Not Operate	9	9
Material Too Soft/Flexible	9	9
Crack	9	9
Activation, Positioning or Separation Problem	8	11
Loose or Intermittent Connection	8	8
Packaging Problem	8	8
Therapeutic or Diagnostic Output Failure	8	8
Component Missing	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Complete Blockage	7	8
Improper or Incorrect Procedure or Method	7	7
Contamination /Decontamination Problem	7	22
Output Problem	6	6
Disconnection	5	33
Dull, Blunt	5	5
Material Puncture/Hole	5	5
Product Quality Problem	5	5
Protective Measures Problem	5	5
Separation Problem	4	4
Entrapment of Device	4	7
Use of Device Problem	4	4
Difficult to Fold, Unfold or Collapse	4	4
Difficult to Insert	3	3
Device Dislodged or Dislocated	3	19

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	696	754
Insufficient Information	212	246
Needle Stick/Puncture	108	108
Foreign Body In Patient	46	46
No Consequences Or Impact To Patient	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	27
Device Embedded In Tissue or Plaque	14	17
Chemical Exposure	10	10
Pain	9	9
Exposure to Body Fluids	4	4
Hemorrhage/Bleeding	4	8
Unintended Radiation Exposure	4	4
Anxiety	3	3
Underdose	3	3
Fever	2	2
No Patient Involvement	2	2
Foreign Body Sensation in Eye	1	1
Injection Site Reaction	1	1
No Information	1	1
Chest Tightness/Pressure	1	1
Discomfort	1	1
Visual Impairment	1	1
Swelling/ Edema	1	1
Loss of Vision	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Nov-08-2024
2	Guangdong Haiou Medical Apparatus Co., Ltd	II	Aug-05-2022
3	Smiths Medical ASD Inc.	I	Jun-10-2021