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	167	167

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	744	744
Failure to Deliver	385	385
Break	151	151
Physical Resistance/Sticking	122	122
Device Contamination with Chemical or Other Material	119	119
Device Markings/Labelling Problem	98	98
Packaging Problem	87	87
Defective Component	59	59
Adverse Event Without Identified Device or Use Problem	49	49
Material Separation	43	43
Volume Accuracy Problem	37	37
Crack	33	33
Mechanical Problem	33	33
Fluid/Blood Leak	32	32
Short Fill	29	29
Contamination	28	28
Defective Device	26	26
Material Deformation	25	25
Infusion or Flow Problem	23	23
Missing Information	22	22
Loose or Intermittent Connection	20	20
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 of Device Ingredient or Reagent	7	7
Disconnection	7	7
Illegible Information	7	7
Material Fragmentation	6	6
Contamination /Decontamination Problem	6	6
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 Discolored	5	5
Nonstandard Device	5	5
Material Twisted/Bent	5	5
Inappropriate Audible Prompt/Feedback	4	4
Connection Problem	4	4
Improper Flow or Infusion	4	4
Free or Unrestricted Flow	3	3
Material Opacification	3	3
Flushing Problem	3	3
Component Incompatible	3	3
Backflow	2	2
Labelling, Instructions for Use or Training Problem	2	2
Inability to Irrigate	2	2
Melted	2	2
Obstruction of Flow	2	2
Structural Problem	2	2
Mechanical Jam	2	2
Difficult or Delayed Activation	2	2
Material Integrity Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Patient Device Interaction Problem	2	2
Insufficient Information	2	2
Device Contaminated at the User Facility	1	1
Wrong Label	1	1
Unexpected Color	1	1
Component Misassembled	1	1
Inaccurate Information	1	1
Sharp Edges	1	1
Audible Prompt/Feedback Problem	1	1
Priming Problem	1	1
Separation Problem	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
Failure to Advance	1	1
Dent in Material	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
Compatibility Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Ingredient or Reagent Problem	1	1
Activation, Positioning or Separation Problem	1	1
Deformation Due to Compressive Stress	1	1
Inaccurate Delivery	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1198	1198
No Known Impact Or Consequence To Patient	402	402
No Consequences Or Impact To Patient	163	163
No Patient Involvement	87	87
Insufficient Information	47	47
No Information	27	27
Bacterial Infection	16	16
Unspecified Infection	12	12
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
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
Purulent Discharge	2	2
Chest Pain	2	2
Cyanosis	2	2
Air Embolism	2	2
Hemorrhage/Bleeding	2	2
Itching Sensation	2	2
Septic Shock	2	2
Rash	2	2
Burning Sensation	2	2
Dizziness	2	2
Tachycardia	2	2
Numbness	2	2
Loss of consciousness	1	1
Fungal Infection	1	1
Needle Stick/Puncture	1	1
Low Oxygen Saturation	1	1
Urinary Tract Infection	1	1
Renal Failure	1	1
Memory Loss/Impairment	1	1
Inflammation	1	1
Headache	1	1
Edema	1	1
Cardiopulmonary Arrest	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