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	2
HANTECH MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDXL, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	497	497
Failure to Deliver	330	330
Break	165	165
Physical Resistance/Sticking	95	95
Device Contamination with Chemical or Other Material	88	88
Defective Component	76	77
Device Markings/Labelling Problem	74	74
Material Separation	62	62
Contamination	60	60
Crack	55	55
Packaging Problem	54	54
Adverse Event Without Identified Device or Use Problem	41	41
Fluid/Blood Leak	38	38
Material Deformation	33	33
Mechanical Problem	30	30
Missing Information	29	29
Short Fill	25	25
Defective Device	25	25
Volume Accuracy Problem	21	21
Contamination /Decontamination Problem	17	17
Air/Gas in Device	16	16
Material Integrity Problem	16	16
Appropriate Term/Code Not Available	15	15
Detachment of Device or Device Component	14	14
Tear, Rip or Hole in Device Packaging	14	14
Loose or Intermittent Connection	14	14
Component Missing	13	13
Partial Blockage	12	12
Fracture	12	12
Complete Blockage	12	12
Difficult to Flush	11	12
Infusion or Flow Problem	10	10
Material Discolored	9	9
Delivered as Unsterile Product	8	8
Nonstandard Device	7	7
Connection Problem	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Separation Problem	6	6
Material Protrusion/Extrusion	5	5
Material Twisted/Bent	5	5
Insufficient Information	5	5
Contamination of Device Ingredient or Reagent	5	5
Microbial Contamination of Device	5	5
Material Fragmentation	5	5
Filling Problem	4	4
Disconnection	4	4
Fungus in Device Environment	4	4
Structural Problem	4	4
Difficult to Advance	4	4
Inaccurate Information	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1584	1587
Insufficient Information	81	82
No Consequences Or Impact To Patient	50	50
Bacterial Infection	15	15
No Patient Involvement	12	12
Unspecified Infection	10	10
Hypersensitivity/Allergic reaction	10	10
Nausea	7	7
Pain	6	6
Sepsis	5	5
Swelling/ Edema	4	4
Anaphylactic Shock	4	4
Laceration(s)	4	4
Shaking/Tremors	3	3
Tachycardia	3	3
Dizziness	3	3
Dyspnea	3	3
Confusion/ Disorientation	3	3
Hemorrhage/Bleeding	2	2
Pneumonia	2	2
Numbness	2	2
Vomiting	2	2
Septic Shock	2	2
Burning Sensation	2	2
Fever	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Purulent Discharge	2	2
Muscle Weakness	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Air Embolism	2	2
Rash	1	1
Needle Stick/Puncture	1	1
Chemical Exposure	1	1
Itching Sensation	1	1
Exposure to Body Fluids	1	1
Chest Pain	1	1
Diarrhea	1	1
Malaise	1	1
Skin Inflammation/ Irritation	1	1
Visual Impairment	1	1
Unspecified Kidney or Urinary Problem	1	1
Memory Loss/Impairment	1	1
Bradycardia	1	1
Fungal Infection	1	1
Drug Resistant Bacterial Infection	1	1
Speech Disorder	1	1
Injection Site Reaction	1	1
Skin Tears	1	1
Convulsion/Seizure	1	1
Dysphasia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	Jan-17-2024
2	Cardinal Health	I	Aug-21-2021
3	Family Dollar Stores, Llc.	II	Aug-17-2022
4	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-08-2022
5	MRP, LLC dba Aquabiliti	II	Feb-22-2024
6	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
7	Medline Industries, LP	II	Oct-23-2025
8	Nurse Assist, LLC	I	Dec-20-2023
9	Windstone Medical Packaging, Inc.	I	Oct-29-2021