TPLC - Total Product Life Cycle

show TPLC since

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	2
BAYER MEDICAL CARE INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K193028 MEDRAD Mark 7 Arterion Injection System
BAYER MEDICAL CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEMOTO KYORINDO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DIZEGENS MEDICAL SCIENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OSPREY MEDICAL INC.
	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	221	221
Manufacturing, Packaging or Shipping Problem	45	45
Insufficient Information	37	37
Detachment of Device or Device Component	33	33
Break	32	32
Inflation Problem	20	20
Activation Problem	17	17
Fluid/Blood Leak	16	19
Contamination /Decontamination Problem	15	15
Gas/Air Leak	14	14
Defective Device	13	13
Air/Gas in Device	13	13
Leak/Splash	11	11
Use of Device Problem	10	10
Mechanical Problem	8	8
Output Problem	8	8
Device Contamination with Chemical or Other Material	7	7
Therapeutic or Diagnostic Output Failure	7	7
Device Contaminated During Manufacture or Shipping	7	7
Product Quality Problem	7	7
Self-Activation or Keying	5	5
Separation Failure	5	5
Material Integrity Problem	5	5
Improper or Incorrect Procedure or Method	5	5
No Apparent Adverse Event	4	4
Defective Component	4	4
Inaccurate Delivery	4	4
Particulates	4	4
Appropriate Term/Code Not Available	4	4
Protective Measures Problem	3	3
Disconnection	3	3
Physical Resistance/Sticking	3	3
Display or Visual Feedback Problem	3	3
Material Disintegration	3	3
Component Missing	3	3
Unexpected Therapeutic Results	3	3
Deflation Problem	3	3
Unsealed Device Packaging	3	3
Pressure Problem	3	3
Material Separation	3	3
Device Fell	3	3
Connection Problem	2	2
Unintended Electrical Shock	2	2
Material Puncture/Hole	2	2
Tear, Rip or Hole in Device Packaging	2	2
Thermal Decomposition of Device	2	2
Unexpected Shutdown	2	2
Premature Activation	2	2
Contamination	2	2
Device Displays Incorrect Message	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	251	254
Air Embolism	166	167
Insufficient Information	59	59
No Patient Involvement	54	54
No Known Impact Or Consequence To Patient	42	42
Cardiac Arrest	34	34
Extravasation	26	26
Not Applicable	15	15
Vascular Dissection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Infiltration into Tissue	8	8
Low Blood Pressure/ Hypotension	8	8
No Consequences Or Impact To Patient	7	7
Death	7	7
Respiratory Failure	7	7
Respiratory Arrest	6	6
Embolism/Embolus	6	6
Embolism	5	5
Chemical Exposure	5	5
Chest Pain	5	5
Ventricular Fibrillation	4	4
Unspecified Tissue Injury	3	3
Electric Shock	3	3
Aneurysm	2	2
Diaphoresis	2	2
Ischemia Stroke	2	2
Arrhythmia	2	2
Myocardial Infarction	2	2
Rupture	1	1
Transient Ischemic Attack	1	1
Atrial Fibrillation	1	1
Swelling/ Edema	1	1
Cough	1	1
Ischemic Heart Disease	1	1
Ventilator Dependent	1	1
No Code Available	1	1
Underdose	1	1
Renal Impairment	1	1
Pain	1	1
Great Vessel Perforation	1	1
Perforation	1	1
Chills	1	1
Eye Injury	1	1
Hemorrhage/Bleeding	1	1
Ischemia	1	1
Fall	1	1
Angina	1	1
Overdose	1	1
Cardiopulmonary Arrest	1	1
Aortic Dissection	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	Bayer Medical Care, Inc.	II	Jan-15-2019
5	LeMaitre Vascular, Inc.	II	May-04-2021
6	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
7	Merit Medical Systems, Inc.	II	Oct-11-2024
8	Merit Medical Systems, Inc.	II	Oct-11-2024