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

MDR Year	MDR Reports	MDR Events
2019	16	16
2020	19	19
2021	13	13
2022	11	11
2023	12	12
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Contamination /Decontamination Problem	24	24
Device Contaminated During Manufacture or Shipping	18	18
Contamination	9	9
Unsealed Device Packaging	5	5
Material Separation	5	5
Nonstandard Device	3	3
Device Contamination with Chemical or Other Material	3	3
Detachment of Device or Device Component	2	2
Packaging Problem	2	2
Complete Blockage	2	2
Defective Component	1	1
Entrapment of Device	1	1
Fluid/Blood Leak	1	1
Mechanical Problem	1	1
Difficult to Advance	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	33	33
No Consequences Or Impact To Patient	23	23
No Patient Involvement	8	8
Foreign Body In Patient	4	4
No Known Impact Or Consequence To Patient	4	4
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Device Embedded In Tissue or Plaque	1	1
Unspecified Tissue Injury	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