TPLC - Total Product Life Cycle

• Device: culture media, non-propagating transport
• Product Code: JSM
• Regulation Number: 866.2390
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ALB LUZ
	SUBSTANTIALLY EQUIVALENT	1
ARX SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
AZER SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOTEKE CORPORATION (WUXI) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
COPAN ITALIA S.P.A.
	SUBSTANTIALLY EQUIVALENT	2
ENSOL BIOSCIENCES INC.
	SUBSTANTIALLY EQUIVALENT	1
HANCHANG MEDIC CO., LTD. (HAN CHANG MEDIC)
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HARDY DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
HUACHENYANG (SHENZHEN) TECHNOLOGY CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDSCHENKER, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUXI NEST BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	81	81
2020	47	47
2021	41	41
2022	36	36
2023	48	48
2024	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	57	57
Leak/Splash	41	41
Break	23	23
Short Fill	20	20
Volume Accuracy Problem	14	14
Product Quality Problem	12	12
Fluid/Blood Leak	11	11
Device Markings/Labelling Problem	11	11
Delivered as Unsterile Product	9	9
Material Protrusion/Extrusion	9	9
Device Contamination with Chemical or Other Material	9	9
Separation Problem	8	8
Component Missing	6	6
Device Ingredient or Reagent Problem	4	4
Physical Resistance/Sticking	4	4
Contamination	4	4
Overfill	4	4
Improper or Incorrect Procedure or Method	3	3
Contamination /Decontamination Problem	3	3
Appropriate Term/Code Not Available	3	3
Missing Information	3	3
Material Separation	3	3
Detachment of Device or Device Component	3	3
False Positive Result	2	2
Complete Blockage	2	2
Premature Separation	2	2
Material Puncture/Hole	2	2
Insufficient Information	2	2
Microbial Contamination of Device	2	2
Difficult to Insert	2	2
Material Discolored	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Deformation	2	2
Noise, Audible	1	1
Nonstandard Device	1	1
Coagulation in Device or Device Ingredient	1	1
Contamination of Device Ingredient or Reagent	1	1
Tear, Rip or Hole in Device Packaging	1	1
Packaging Problem	1	1
Misassembly During Maintenance/Repair	1	1
Flare or Flash	1	1
Shipping Damage or Problem	1	1
Defective Device	1	1
Filling Problem	1	1
Crack	1	1
Material Opacification	1	1
Mechanical Problem	1	1
False Negative Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	123	123
No Known Impact Or Consequence To Patient	77	77
No Consequences Or Impact To Patient	18	18
Needle Stick/Puncture	15	15
Foreign Body In Patient	12	12
Insufficient Information	7	7
No Patient Involvement	6	6
Exposure to Body Fluids	3	3
No Information	2	2
Blood Loss	2	2
Patient Problem/Medical Problem	1	1
No Code Available	1	1
Test Result	1	1
Chemical Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems, Inc.	II	Oct-08-2022
2	American Contract Systems, Inc.	I	Jul-01-2022
3	Cepheid	II	Aug-14-2024
4	Gentueri Inc	II	Feb-04-2022
5	Gentueri Inc	II	Jan-18-2022
6	Hardy Diagnostics	II	Dec-21-2020
7	Krishe Inc	II	Apr-13-2021
8	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
9	Merit Medical Systems, Inc.	II	Nov-16-2020