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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contaminated During Manufacture or Shipping	25	25
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
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	46	46
No Consequences Or Impact To Patient	14	14
No Patient Involvement	6	6
Foreign Body In Patient	4	4
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