TPLC - Total Product Life Cycle

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Device	saline, vascular access flush
Regulation Description	Intravascular catheter.
Definition	Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Product Code	NGT
Regulation Number	880.5200
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMSINO INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BD
	SUBSTANTIALLY EQUIVALENT	2
BECTON DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON & CO.
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
HOSPIRA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
NURSE ASSIST, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak / Splash	236
Packaging Problem	32
Device Contamination with Chemical or Other Material	29
Appropriate Term/Code Not Available	28
Device Markings / Labelling Problem	21
Break	16
Failure to Deliver	14
Volume Accuracy Problem	13
Infusion or Flow Problem	10
Device Contaminated during manufacture or shipping	7
Material Fragmentation	6
Short Fill	6
Manufacturing, Packaging or Shipping Problem	5
Loose or Intermittent Connection	5
Nonstandard device	5
Material Protrusion / Extrusion	4
Adverse Event Without Identified Device or Use Problem	4
Illegible Information	4
Product Quality Problem	4
Material Deformation	3
Delivered as Unsterile Product	3
Material Discolored	3
Inappropriate Audible Prompt / Feedback	2
Unsealed Device Packaging	2
Device Packaging Compromised	2
Device Operates Differently Than Expected	2
Free or Unrestricted Flow	2
Complete Blockage	1
Syringe	1
Fitting Problem	1
No Pressure	1
Pressure Problem	1
Plunger	1
Degraded	1
Defective Component	1
Difficult or Delayed Activation	1
Labelling, Instructions for Use or Training Problem	1
Total Device Problems	478