TPLC - Total Product Life Cycle

• Device: enteral specific transition connectors
• 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 LG
	SUBSTANTIALLY EQUIVALENT	1
GBUK GROUP LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	7	7
2020	6	6
2021	9	9
2022	5	5
2023	10	10
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Deliver	14	14
Break	4	4
Crack	3	3
Separation Failure	3	3
Material Integrity Problem	3	3
Use of Device Problem	3	3
Connection Problem	2	2
Leak/Splash	2	2
Difficult to Remove	1	1
Material Separation	1	1
Entrapment of Device	1	1
Free or Unrestricted Flow	1	1
Infusion or Flow Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Output Problem	1	1
Appropriate Term/Code Not Available	1	1
Patient Device Interaction Problem	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
No Known Impact Or Consequence To Patient	11	11
Foreign Body In Patient	5	5
Insufficient Information	3	3
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