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
JIANGSU CAINA MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDXL INC.
	SUBSTANTIALLY EQUIVALENT	2
NURSE ASSIST, LLC
	SUBSTANTIALLY EQUIVALENT	1
PENTAFERTE ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	269	269
2019	340	340
2020	322	322
2021	566	566
2022	282	282
2023	210	210

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	725	725
Failure to Deliver	383	383
Break	184	184
Device Contamination with Chemical or Other Material	125	125
Physical Resistance/Sticking	107	107
Device Markings/Labelling Problem	95	95
Packaging Problem	90	90
Adverse Event Without Identified Device or Use Problem	57	57
Defective Component	49	49
Device Damaged Prior to Use	34	34
Volume Accuracy Problem	31	31
Fluid/Blood Leak	30	30
Short Fill	28	28
Material Separation	24	24
Crack	24	24
Contamination	23	23
Infusion or Flow Problem	22	22
Material Deformation	20	20
Defective Device	20	20
Loose or Intermittent Connection	19	19
Difficult to Advance	19	19
Detachment of Device or Device Component	18	18
Missing Information	18	18
Nonstandard Device	16	16
Component Missing	15	15
Difficult to Flush	12	12
Partial Blockage	12	12
Complete Blockage	11	11
Material Discolored	11	11
Microbial Contamination of Device	11	11
Patient-Device Incompatibility	10	10
Delivered as Unsterile Product	10	10
Insufficient Information	10	10
Appropriate Term/Code Not Available	10	10
Material Protrusion/Extrusion	9	9
Air/Gas in Device	9	9
Mechanical Problem	9	9
Disconnection	8	8
Physical Resistance	6	6
Tear, Rip or Hole in Device Packaging	6	6
Illegible Information	6	6
Contamination /Decontamination Problem	6	6
Contamination of Device Ingredient or Reagent	6	6
Material Twisted/Bent	5	5
Improper Flow or Infusion	5	5
Fungus in Device Environment	5	5
Failure to Advance	4	4
Inappropriate Audible Prompt/Feedback	4	4
Detachment Of Device Component	4	4
Device Operates Differently Than Expected	4	4
Device Packaging Compromised	4	4
Free or Unrestricted Flow	3	3
Component Incompatible	3	3
Backflow	3	3
Flushing Problem	3	3
Unsealed Device Packaging	3	3
Out-Of-Box Failure	3	3
Structural Problem	3	3
Obstruction of Flow	2	2
Difficult or Delayed Activation	2	2
Device Slipped	2	2
Problem with Sterilization	2	2
Product Quality Problem	2	2
Device Emits Odor	2	2
Material Opacification	2	2
Melted	2	2
Inability to Irrigate	2	2
Entrapment of Device	2	2
Mechanical Jam	2	2
Difficult to Open or Remove Packaging Material	2	2
Activation, Positioning or Separation Problem	2	2
Patient Device Interaction Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Positioning Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Unintended Movement	2	2
Inaccurate Information	1	1
Wrong Label	1	1
Unexpected Color	1	1
Pressure Problem	1	1
Pumping Problem	1	1
Physical Property Issue	1	1
No Pressure	1	1
Component Misassembled	1	1
Sharp Edges	1	1
Audible Prompt/Feedback Problem	1	1
Priming Problem	1	1
Separation Problem	1	1
Device Ingredient or Reagent Problem	1	1
Moisture or Humidity Problem	1	1
Compatibility Problem	1	1
Filling Problem	1	1
Unintended System Motion	1	1
Particulates	1	1
Difficult To Position	1	1
Precipitate in Device or Device Ingredient	1	1
Increase in Pressure	1	1
Failure to Prime	1	1
Material Fragmentation	1	1
Image Display Error/Artifact	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	946	946
No Known Impact Or Consequence To Patient	534	534
No Consequences Or Impact To Patient	223	223
No Patient Involvement	102	102
No Information	43	43
Insufficient Information	32	32
Bacterial Infection	20	20
Unspecified Infection	20	20
Pain	10	10
Hypersensitivity/Allergic reaction	9	9
Swelling	8	8
Reaction	8	8
Vomiting	7	7
Death	7	7
Sepsis	5	5
Nausea	5	5
No Code Available	5	5
Laceration(s)	4	4
Rash	4	4
Dyspnea	4	4
Fever	4	4
Anaphylactic Shock	3	3
Itching Sensation	3	3
Chemical Exposure	3	3
Swelling/ Edema	3	3
Loss of consciousness	3	3
Sweating	2	2
Underdose	2	2
Confusion/ Disorientation	2	2
Dizziness	2	2
Burning Sensation	2	2
Numbness	2	2
Discomfort	2	2
Blood Loss	2	2
Shaking/Tremors	2	2
Septic Shock	2	2
Cyanosis	2	2
Cardiac Arrest	2	2
Air Embolism	2	2
Edema	2	2
Erythema	2	2
Gangrene	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Syncope	1	1
Exposure to Body Fluids	1	1
Cardiopulmonary Arrest	1	1
Chest Pain	1	1
Skin Irritation	1	1
Memory Loss/Impairment	1	1
Tachycardia	1	1
Therapeutic Effects, Unexpected	1	1
Thrombus	1	1
Urinary Tract Infection	1	1
Inflammation	1	1
Renal Failure	1	1
Respiratory Distress	1	1
Skin Tears	1	1
Convulsion/Seizure	1	1
Skin Inflammation/ Irritation	1	1
Injection Site Reaction	1	1
Alteration In Body Temperature	1	1
Patient Problem/Medical Problem	1	1
Malaise	1	1
Chills	1	1
Lethargy	1	1
Loss Of Pulse	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	May-21-2020
2	Becton Dickinson & Company	II	Nov-20-2019
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	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
7	Medline Industries Inc	II	Aug-29-2018
8	Windstone Medical Packaging, Inc.	I	Oct-29-2021