TPLC - Total Product Life Cycle

• Device: catheter, assisted reproduction
• Regulation Description: Assisted reproduction catheters.
• Product Code: MQF
• Regulation Number: 884.6110
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALLWIN MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
FEMASYS INC.
	SUBSTANTIALLY EQUIVALENT	1
KITAZATO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI HORIZON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN VITAVITRO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	19	19
2021	13	13
2022	11	11
2023	12	12
2024	15	15
2025	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contaminated During Manufacture or Shipping	29	29
Contamination	14	14
Contamination /Decontamination Problem	12	12
Unsealed Device Packaging	4	4
Material Separation	4	4
Complete Blockage	3	3
Packaging Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Nonstandard Device	3	3
Entrapment of Device	1	1
Mechanical Problem	1	1
Difficult to Advance	1	1
Defective Component	1	1
Material Fragmentation	1	1
Obstruction of Flow	1	1
Infusion or Flow Problem	1	1
Detachment of Device or Device Component	1	1
Material Protrusion/Extrusion	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	50	50
No Consequences Or Impact To Patient	14	14
No Patient Involvement	6	6
Foreign Body In Patient	5	5
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Tenderneeds Fertility LLC	II	Aug-02-2021
2	Tenderneeds Fertility LLC	II	Apr-06-2021