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
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	637	637
Failure to Deliver	382	382
Break	170	170
Device Contamination with Chemical or Other Material	117	117
Physical Resistance/Sticking	104	104
Packaging Problem	86	86
Device Markings/Labelling Problem	84	84
Defective Component	76	76
Material Separation	65	65
Contamination	47	47
Crack	40	40
Adverse Event Without Identified Device or Use Problem	38	38
Fluid/Blood Leak	38	38
Mechanical Problem	30	30
Material Deformation	30	30
Volume Accuracy Problem	30	30
Missing Information	29	29
Short Fill	26	26
Defective Device	25	25
Infusion or Flow Problem	20	20
Loose or Intermittent Connection	18	18
Appropriate Term/Code Not Available	15	15
Difficult to Flush	13	13
Complete Blockage	12	12
Fracture	12	12
Partial Blockage	12	12
Component Missing	12	12
Detachment of Device or Device Component	12	12
Material Integrity Problem	10	10
Air/Gas in Device	9	9
Delivered as Unsterile Product	9	9
Contamination /Decontamination Problem	7	7
Tear, Rip or Hole in Device Packaging	7	7
Material Protrusion/Extrusion	7	7
Material Fragmentation	6	6
Separation Problem	6	6
Material Discolored	5	5
Connection Problem	5	5
Illegible Information	5	5
Contamination of Device Ingredient or Reagent	5	5
Insufficient Information	5	5
Fungus in Device Environment	5	5
Nonstandard Device	5	5
Microbial Contamination of Device	5	5
Material Twisted/Bent	4	4
Difficult to Advance	4	4
Structural Problem	4	4
Disconnection	4	4
Improper Flow or Infusion	3	3
Manufacturing, Packaging or Shipping Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1446	1446
No Consequences Or Impact To Patient	159	159
No Known Impact Or Consequence To Patient	134	134
Insufficient Information	79	79
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
Anaphylactic Shock	4	4
Confusion/ Disorientation	3	3
No Information	3	3
Swelling/ Edema	3	3
Dyspnea	3	3
Numbness	2	2
Hemorrhage/Bleeding	2	2
Fever	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
Dizziness	2	2
Vomiting	2	2
Tachycardia	2	2
Septic Shock	2	2
Pneumonia	2	2
Nausea	2	2
Chemical Exposure	2	2
Burning Sensation	1	1
Bradycardia	1	1
Cardiopulmonary Arrest	1	1
Swelling	1	1
Rash	1	1
Diarrhea	1	1
Memory Loss/Impairment	1	1
Headache	1	1
Itching Sensation	1	1
Unspecified Kidney or Urinary Problem	1	1
Low Blood Pressure/ Hypotension	1	1
Convulsion/Seizure	1	1
Inflammation	1	1
Skin Inflammation/ Irritation	1	1
Drug Resistant Bacterial Infection	1	1
Injection Site Reaction	1	1
No Code Available	1	1
Device Embedded In Tissue or Plaque	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