TPLC - Total Product Life Cycle

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Device	non-coring (huber) needle
Regulation Description	Hypodermic single lumen 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
BARD ACCESS SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERA ONCOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU CAINA MEDICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SB-KAWASUMI LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	37	37
Fail-Safe Did Not Operate	14	14
Break	12	12
Fail-Safe Problem	10	10
Material Twisted/Bent	6	6
Device Handling Problem	5	5
Loss of or Failure to Bond	5	5
Leak/Splash	4	4
Crack	4	4
Activation Problem	2	3
Difficult to Flush	2	2
Air/Gas in Device	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Deformation	2	2
Product Quality Problem	2	2
Appropriate Term/Code Not Available	2	2
Output Problem	1	1
Defective Component	1	1
Contamination /Decontamination Problem	1	1
Material Separation	1	1
Device Contamination with Chemical or Other Material	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	73
Needle Stick/Puncture	27	27
Insufficient Information	6	6
Extravasation	3	3
Hemorrhage/Bleeding	1	1
Itching Sensation	1	1
Pain	1	1
Discomfort	1	1
Exposure to Body Fluids	1	1
Skin Tears	1	1
Skin Infection	1	1