TPLC - Total Product Life Cycle

• Device: cap, device disinfectant
• Regulation Description: Intravascular administration set.
• Definition: Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
• Product Code: QBP
• Regulation Number: 880.5440
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CLEANSITE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ICU MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
STAR MOUNTAIN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	1	1
2023	1	1
2024	1	1
2025	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3	3
Fluid/Blood Leak	3	3
Material Integrity Problem	2	2
Use of Device Problem	2	2
Component Missing	2	2
Detachment of Device or Device Component	2	2
Device Markings/Labelling Problem	1	1
Defective Component	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Patient Device Interaction Problem	1	1
Gas/Air Leak	1	1
Device Contamination with Chemical or Other Material	1	1
Protective Measures Problem	1	1
Difficult to Open or Close	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
Insufficient Information	2	2
Dyspnea	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ICU Medical, Inc.	II	Jul-11-2025
2	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-30-2025