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
FEMASYS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU HEHONG BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI HORIZON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN VITAVITRO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VITROLIFE SWEDEN AB
	SUBSTANTIALLY EQUIVALENT	1

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contaminated During Manufacture or Shipping	33	33
Contamination	14	14
Contamination /Decontamination Problem	5	5
Unsealed Device Packaging	4	4
Complete Blockage	3	3
Packaging Problem	2	2
Nonstandard Device	2	2
Material Separation	2	2
Material Deformation	1	1
Material Protrusion/Extrusion	1	1
Mechanical Problem	1	1
Material Fragmentation	1	1
Defective Component	1	1
Obstruction of Flow	1	1
Difficult to Advance	1	1
Device Contamination with Chemical or Other Material	1	1
Infusion or Flow Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	57
Foreign Body In Patient	3	3
Insufficient Information	2	2
No Consequences Or Impact To Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Patient Involvement	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