TPLC - Total Product Life Cycle

• Device: enteral specific transition connectors
• Regulation Description: Gastrointestinal tube and accessories.
• Definition: Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
• Product Code: PIO
• Regulation Number: 876.5980
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CAIR LGL
	SUBSTANTIALLY EQUIVALENT	1
GBUK GROUP, LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	6	6
2021	9	9
2022	5	7
2023	10	10
2024	6	6
2025	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Deliver	8	8
Break	4	4
Leak/Splash	3	3
Crack	3	3
Separation Failure	3	3
Material Integrity Problem	3	3
Use of Device Problem	3	3
Infusion or Flow Problem	3	3
Detachment of Device or Device Component	2	2
Free or Unrestricted Flow	2	2
Connection Problem	2	2
Fluid/Blood Leak	2	2
Separation Problem	1	1
Entrapment of Device	1	1
Manufacturing, Packaging or Shipping Problem	1	3
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Material Separation	1	1
Appropriate Term/Code Not Available	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	22	24
Insufficient Information	10	10
Foreign Body In Patient	5	5
No Known Impact Or Consequence To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Choking	2	2
Cellulitis	1	1
Feeding Problem	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Technology Inc	III	Dec-23-2020