TPLC - Total Product Life Cycle

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Device	injector and syringe, angiographic
Regulation Description	Angiographic injector and syringe.
Product Code	DXT
Regulation Number	870.1650
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACIST MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEMOTO KYORINDO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DIZEGENS MEDICAL SCIENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PRECISION MEDICAL PLASTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG INT MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN BOON MEDICAL SUPPLY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN BOON MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YOUWO (GUANGZHOU) MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	191	191
Insufficient Information	37	37
Manufacturing, Packaging or Shipping Problem	32	32
Break	29	29
Detachment of Device or Device Component	18	18
Activation Problem	17	17
Air/Gas in Device	13	13
Fluid/Blood Leak	13	16
Defective Device	11	11
Contamination /Decontamination Problem	10	10
Inflation Problem	10	10
Gas/Air Leak	8	8
Mechanical Problem	7	7
Output Problem	7	7
Use of Device Problem	7	7
Leak/Splash	7	7
Therapeutic or Diagnostic Output Failure	6	6
Separation Failure	4	4
Self-Activation or Keying	4	4
Defective Component	4	4
No Apparent Adverse Event	4	4
Inaccurate Delivery	3	3
Product Quality Problem	3	3
Appropriate Term/Code Not Available	3	3
Physical Resistance/Sticking	3	3
Improper or Incorrect Procedure or Method	3	3
Pressure Problem	3	3
Unexpected Therapeutic Results	3	3
Component Missing	3	3
Material Separation	3	3
Unsealed Device Packaging	3	3
Disconnection	3	3
Deflation Problem	3	3
Explosion	2	2
Protective Measures Problem	2	2
Improper Flow or Infusion	2	2
Connection Problem	2	2
Device Difficult to Setup or Prepare	2	2
Unintended Ejection	2	2
Tear, Rip or Hole in Device Packaging	2	2
Backflow	2	2
Contamination	2	2
Material Integrity Problem	2	2
Device Fell	2	2
Display or Visual Feedback Problem	2	2
Material Puncture/Hole	2	2
Unintended Electrical Shock	2	2
Device Markings/Labelling Problem	2	2
Loose or Intermittent Connection	2	2
Fire	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	252	255
Air Embolism	144	144
Insufficient Information	59	59
Cardiac Arrest	32	32
Extravasation	22	22
No Patient Involvement	18	18
No Known Impact Or Consequence To Patient	17	17
Infiltration into Tissue	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Respiratory Failure	7	7
Low Blood Pressure/ Hypotension	7	7
Vascular Dissection	7	7
Respiratory Arrest	6	6
Embolism/Embolus	6	6
Chest Pain	5	5
Chemical Exposure	4	4
Electric Shock	3	3
No Consequences Or Impact To Patient	3	3
Unspecified Tissue Injury	3	3
Death	3	3
Ischemia Stroke	2	2
Myocardial Infarction	2	2
Aneurysm	2	2
Arrhythmia	2	2
Ventricular Fibrillation	2	2
Diaphoresis	2	2
Obstruction/Occlusion	1	1
Overdose	1	1
Stroke/CVA	1	1
Angina	1	1
Rupture	1	1
Chills	1	1
Injury	1	1
Diminished Pulse Pressure	1	1
Ischemic Heart Disease	1	1
Malaise	1	1
Dyspnea	1	1
Fall	1	1
Pain	1	1
Renal Impairment	1	1
Eye Injury	1	1
Non specific EKG/ECG Changes	1	1
Cough	1	1
Vasoconstriction	1	1
Swelling/ Edema	1	1
Perforation	1	1
Ischemia	1	1
Great Vessel Perforation	1	1
Underdose	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B. Braun Medical, Inc.	II	Nov-03-2023
2	Bayer Medical Care, Inc.	II	Nov-03-2021
3	Bayer Medical Care, Inc.	II	Nov-23-2020
4	LeMaitre Vascular, Inc.	II	May-04-2021
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	Merit Medical Systems, Inc.	II	Oct-11-2024
7	Merit Medical Systems, Inc.	II	Oct-11-2024