TPLC - Total Product Life Cycle

• Device: catheter, assisted reproduction
• Product Code: MQF
• Regulation Number: 884.6110
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALLWIN MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOK INCORPORATED
	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
2019	16	16
2020	19	19
2021	13	13
2022	11	11
2023	12	12
2024	14	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contaminated During Manufacture or Shipping	25	25
Contamination /Decontamination Problem	24	24
Contamination	13	13
Unsealed Device Packaging	5	5
Material Separation	5	5
Complete Blockage	3	3
Packaging Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Nonstandard Device	3	3
Detachment of Device or Device Component	2	2
Entrapment of Device	1	1
Mechanical Problem	1	1
Difficult to Advance	1	1
Defective Component	1	1
Infusion or Flow Problem	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	45	45
No Consequences Or Impact To Patient	23	23
No Patient Involvement	8	8
No Known Impact Or Consequence To Patient	4	4
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
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Nov-16-2019
2	Tenderneeds Fertility LLC	II	Aug-02-2021
3	Tenderneeds Fertility LLC	II	Apr-06-2021