TPLC - Total Product Life Cycle

• Device: non-coring (huber) needle
• Definition: The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.
• Product Code: PTI
• Regulation Number: 880.5570
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
INTERA ONCOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU CAINA MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	12	12
2020	12	12
2021	17	17
2022	13	13
2023	9	9
2024	31	31

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	28	28
Break	14	14
Protective Measures Problem	12	12
Fail-Safe Did Not Operate	10	10
Fail-Safe Problem	10	10
Leak/Splash	5	5
Crack	5	5
Material Twisted/Bent	5	5
Device Handling Problem	5	5
Air/Gas in Device	2	2
Output Problem	1	1
Activation Problem	1	1
Contamination /Decontamination Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Deformation	1	1
Product Quality Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	44
Needle Stick/Puncture	26	26
No Known Impact Or Consequence To Patient	12	12
Insufficient Information	6	6
Foreign Body In Patient	4	4
Exposure to Body Fluids	3	3
Skin Tears	2	2
Skin Infection	1	1
Blood Loss	1	1
Itching Sensation	1	1
Discomfort	1	1
Pain	1	1
Extravasation	1	1
No Consequences Or Impact To Patient	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	Jul-20-2020