TPLC - Total Product Life Cycle

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Device	saline, vascular access flush
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
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	629	629
Failure to Deliver	382	382
Break	162	162
Device Contamination with Chemical or Other Material	110	110
Physical Resistance/Sticking	104	104
Packaging Problem	85	85
Device Markings/Labelling Problem	79	79
Defective Component	73	73
Material Separation	58	58
Contamination	38	38
Fluid/Blood Leak	37	37
Adverse Event Without Identified Device or Use Problem	36	36
Crack	35	35
Mechanical Problem	30	30
Volume Accuracy Problem	29	29
Missing Information	28	28
Material Deformation	28	28
Short Fill	25	25
Defective Device	22	22
Infusion or Flow Problem	20	20
Loose or Intermittent Connection	18	18
Difficult to Flush	13	13
Component Missing	12	12
Partial Blockage	12	12
Detachment of Device or Device Component	12	12
Complete Blockage	12	12
Fracture	12	12
Appropriate Term/Code Not Available	10	10
Air/Gas in Device	9	9
Delivered as Unsterile Product	8	8
Tear, Rip or Hole in Device Packaging	7	7
Material Protrusion/Extrusion	6	6
Material Integrity Problem	6	6
Contamination of Device Ingredient or Reagent	5	5
Illegible Information	5	5
Separation Problem	5	5
Microbial Contamination of Device	5	5
Nonstandard Device	5	5
Fungus in Device Environment	5	5
Material Fragmentation	5	5
Connection Problem	5	5
Material Twisted/Bent	4	4
Material Discolored	4	4
Disconnection	4	4
Difficult to Advance	4	4
Contamination /Decontamination Problem	4	4
Insufficient Information	4	4
Component Incompatible	3	3
Material Opacification	3	3
Improper Flow or Infusion	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1374	1374
No Consequences Or Impact To Patient	159	159
No Known Impact Or Consequence To Patient	134	134
No Patient Involvement	71	71
Insufficient Information	70	70
Bacterial Infection	17	17
Unspecified Infection	10	10
Pain	7	7
Hypersensitivity/Allergic reaction	6	6
Sepsis	5	5
Laceration(s)	4	4
No Information	3	3
Anaphylactic Shock	3	3
Swelling/ Edema	3	3
Confusion/ Disorientation	3	3
Dyspnea	2	2
Pneumonia	2	2
Numbness	2	2
Vomiting	2	2
Septic Shock	2	2
Chest Pain	2	2
Exposure to Body Fluids	2	2
Tachycardia	2	2
Fever	2	2
Chemical Exposure	2	2
Purulent Discharge	2	2
Dizziness	2	2
Nausea	2	2
Death	2	2
Cyanosis	2	2
Air Embolism	2	2
Shaking/Tremors	1	1
Skin Tears	1	1
Underdose	1	1
Convulsion/Seizure	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Loss of consciousness	1	1
Bradycardia	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Unspecified Kidney or Urinary Problem	1	1
Cardiopulmonary Arrest	1	1
Swelling	1	1
Diarrhea	1	1
Loss Of Pulse	1	1
Needle Stick/Puncture	1	1
Burning Sensation	1	1
Blood Loss	1	1
Itching Sensation	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