TPLC - Total Product Life Cycle

• 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	2
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
MEDLINE INDUSTRIES, INC.
	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

MDR Year	MDR Reports	MDR Events
2019	340	340
2020	322	322
2021	566	566
2022	282	282
2023	334	334
2024	190	190

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	746	746
Failure to Deliver	385	385
Break	152	152
Device Contamination with Chemical or Other Material	122	122
Physical Resistance/Sticking	122	122
Device Markings/Labelling Problem	98	98
Packaging Problem	87	87
Defective Component	60	60
Adverse Event Without Identified Device or Use Problem	49	49
Material Separation	45	45
Volume Accuracy Problem	37	37
Fluid/Blood Leak	35	35
Crack	33	33
Mechanical Problem	33	33
Contamination	29	29
Short Fill	29	29
Defective Device	26	26
Material Deformation	25	25
Infusion or Flow Problem	23	23
Missing Information	23	23
Loose or Intermittent Connection	21	21
Detachment of Device or Device Component	16	16
Difficult to Flush	15	15
Partial Blockage	12	12
Complete Blockage	12	12
Appropriate Term/Code Not Available	12	12
Delivered as Unsterile Product	11	11
Component Missing	11	11
Difficult to Advance	10	10
Fracture	10	10
Air/Gas in Device	9	9
Material Protrusion/Extrusion	8	8
Patient-Device Incompatibility	8	8
Contamination /Decontamination Problem	7	7
Contamination of Device Ingredient or Reagent	7	7
Disconnection	7	7
Illegible Information	7	7
Material Fragmentation	6	6
Material Discolored	5	5
Nonstandard Device	5	5
Fungus in Device Environment	5	5
Microbial Contamination of Device	5	5
Tear, Rip or Hole in Device Packaging	5	5
Device Damaged Prior to Use	5	5
Material Twisted/Bent	5	5
Material Integrity Problem	5	5
Inappropriate Audible Prompt/Feedback	4	4
Connection Problem	4	4
Improper Flow or Infusion	4	4
Free or Unrestricted Flow	3	3
Structural Problem	3	3
Material Opacification	3	3
Flushing Problem	3	3
Component Incompatible	3	3
Insufficient Information	3	3
Patient Device Interaction Problem	2	2
Difficult or Delayed Activation	2	2
Mechanical Jam	2	2
Therapeutic or Diagnostic Output Failure	2	2
Backflow	2	2
Labelling, Instructions for Use or Training Problem	2	2
Inability to Irrigate	2	2
Melted	2	2
Difficult to Open or Remove Packaging Material	2	2
Obstruction of Flow	2	2
Inaccurate Delivery	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Device Slipped	1	1
Problem with Sterilization	1	1
Use of Device Problem	1	1
Device Ingredient or Reagent Problem	1	1
Compatibility Problem	1	1
Failure to Advance	1	1
Dent in Material	1	1
Deformation Due to Compressive Stress	1	1
Activation, Positioning or Separation Problem	1	1
Device Emits Odor	1	1
Unintended System Motion	1	1
Unsealed Device Packaging	1	1
Particulates	1	1
Failure to Prime	1	1
Product Quality Problem	1	1
Unable to Obtain Readings	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Retraction Problem	1	1
Excess Flow or Over-Infusion	1	1
Entrapment of Device	1	1
Device Alarm System	1	1
Positioning Failure	1	1
Unintended Movement	1	1
No Pressure	1	1
Positioning Problem	1	1
Pressure Problem	1	1
Pumping Problem	1	1
No Flow	1	1
Component Misassembled	1	1
Inaccurate Information	1	1
Sharp Edges	1	1
Audible Prompt/Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1217	1217
No Known Impact Or Consequence To Patient	402	402
No Consequences Or Impact To Patient	163	163
No Patient Involvement	87	87
Insufficient Information	49	49
No Information	27	27
Bacterial Infection	16	16
Unspecified Infection	13	13
Hypersensitivity/Allergic reaction	9	9
Pain	9	9
Swelling	7	7
Reaction	6	6
Nausea	6	6
Sepsis	5	5
Vomiting	5	5
Laceration(s)	4	4
Dyspnea	4	4
Fever	4	4
Exposure to Body Fluids	3	3
Anaphylactic Shock	3	3
Death	3	3
Tachycardia	3	3
No Code Available	3	3
Chemical Exposure	3	3
Swelling/ Edema	3	3
Blood Loss	2	2
Underdose	2	2
Confusion/ Disorientation	2	2
Malaise	2	2
Shaking/Tremors	2	2
Burning Sensation	2	2
Dizziness	2	2
Numbness	2	2
Itching Sensation	2	2
Septic Shock	2	2
Rash	2	2
Purulent Discharge	2	2
Chest Pain	2	2
Cyanosis	2	2
Air Embolism	2	2
Hemorrhage/Bleeding	2	2
Inflammation	1	1
Headache	1	1
Edema	1	1
Cardiopulmonary Arrest	1	1
Renal Failure	1	1
Memory Loss/Impairment	1	1
Loss of consciousness	1	1
Fungal Infection	1	1
Needle Stick/Puncture	1	1
Low Oxygen Saturation	1	1
Urinary Tract Infection	1	1
Skin Tears	1	1
Loss Of Pulse	1	1
Convulsion/Seizure	1	1
Skin Inflammation/ Irritation	1	1
Drug Resistant Bacterial Infection	1	1
Injection Site Reaction	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Alteration In Body Temperature	1	1
Patient Problem/Medical Problem	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	Becton Dickinson & Company	II	Nov-20-2019
4	Cardinal Health	I	Aug-21-2021
5	Family Dollar Stores, Llc.	II	Aug-17-2022
6	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-08-2022
7	MRP, LLC dba Aquabiliti	II	Feb-22-2024
8	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
9	Nurse Assist, LLC	I	Dec-20-2023
10	Windstone Medical Packaging, Inc.	I	Oct-29-2021