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
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANHUI TIANYANG PHARMACEUTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
HANTECH MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDXL INC.
	SUBSTANTIALLY EQUIVALENT	3
NURSE ASSIST, LLC
	SUBSTANTIALLY EQUIVALENT	1
1. K201286 0.9% Sodium Chloride I.V. Flush Syringe for Steril ...
PENTAFERTE ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SPM MEDICARE PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	633	633
Failure to Deliver	382	382
Break	165	165
Device Contamination with Chemical or Other Material	114	114
Physical Resistance/Sticking	104	104
Packaging Problem	86	86
Device Markings/Labelling Problem	80	80
Defective Component	74	74
Material Separation	59	59
Contamination	41	41
Fluid/Blood Leak	37	37
Adverse Event Without Identified Device or Use Problem	36	36
Crack	35	35
Mechanical Problem	30	30
Material Deformation	29	29
Volume Accuracy Problem	29	29
Missing Information	29	29
Short Fill	25	25
Defective Device	23	23
Infusion or Flow Problem	20	20
Loose or Intermittent Connection	18	18
Difficult to Flush	13	13
Partial Blockage	12	12
Detachment of Device or Device Component	12	12
Fracture	12	12
Component Missing	12	12
Complete Blockage	12	12
Appropriate Term/Code Not Available	10	10
Air/Gas in Device	9	9
Delivered as Unsterile Product	9	9
Tear, Rip or Hole in Device Packaging	7	7
Separation Problem	6	6
Material Fragmentation	6	6
Material Integrity Problem	6	6
Material Protrusion/Extrusion	6	6
Fungus in Device Environment	5	5
Contamination of Device Ingredient or Reagent	5	5
Nonstandard Device	5	5
Illegible Information	5	5
Connection Problem	5	5
Microbial Contamination of Device	5	5
Material Discolored	4	4
Disconnection	4	4
Material Twisted/Bent	4	4
Insufficient Information	4	4
Difficult to Advance	4	4
Contamination /Decontamination Problem	4	4
Component Incompatible	3	3
Labelling, Instructions for Use or Training Problem	3	3
Material Opacification	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1397	1397
No Consequences Or Impact To Patient	159	159
No Known Impact Or Consequence To Patient	134	134
Insufficient Information	72	72
No Patient Involvement	71	71
Bacterial Infection	17	17
Unspecified Infection	10	10
Pain	7	7
Hypersensitivity/Allergic reaction	6	6
Sepsis	5	5
Laceration(s)	4	4
Confusion/ Disorientation	3	3
No Information	3	3
Anaphylactic Shock	3	3
Swelling/ Edema	3	3
Septic Shock	2	2
Pneumonia	2	2
Nausea	2	2
Tachycardia	2	2
Vomiting	2	2
Dizziness	2	2
Numbness	2	2
Fever	2	2
Dyspnea	2	2
Purulent Discharge	2	2
Death	2	2
Cyanosis	2	2
Chest Pain	2	2
Exposure to Body Fluids	2	2
Air Embolism	2	2
Chemical Exposure	2	2
Loss of consciousness	1	1
Malaise	1	1
Fungal Infection	1	1
Burning Sensation	1	1
Needle Stick/Puncture	1	1
Low Oxygen Saturation	1	1
Swelling	1	1
Respiratory Failure	1	1
Shaking/Tremors	1	1
Skin Tears	1	1
Underdose	1	1
Memory Loss/Impairment	1	1
Itching Sensation	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Injection Site Reaction	1	1
Drug Resistant Bacterial Infection	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	Jan-17-2024
2	Becton Dickinson & Company	II	May-21-2020
3	Cardinal Health	I	Aug-21-2021
4	Family Dollar Stores, Llc.	II	Aug-17-2022
5	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-08-2022
6	MRP, LLC dba Aquabiliti	II	Feb-22-2024
7	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
8	Nurse Assist, LLC	I	Dec-20-2023
9	Windstone Medical Packaging, Inc.	I	Oct-29-2021