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
1. K232388 High Pressure Tubing
PRECISION MEDICAL PLASTICS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG INT MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN BOON MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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	233	233
Insufficient Information	48	48
Manufacturing, Packaging or Shipping Problem	33	33
Break	31	35
Detachment of Device or Device Component	18	18
Activation Problem	17	17
Fluid/Blood Leak	14	17
Air/Gas in Device	14	15
Defective Device	12	12
Contamination /Decontamination Problem	11	11
Mechanical Problem	11	11
Inflation Problem	10	10
Gas/Air Leak	8	8
Leak/Splash	8	8
Use of Device Problem	7	7
Product Quality Problem	7	7
Output Problem	7	7
Therapeutic or Diagnostic Output Failure	6	6
Unintended Movement	5	5
Contamination	4	8
Defective Component	4	4
Material Separation	4	4
Unsealed Device Packaging	4	4
Separation Failure	4	4
No Apparent Adverse Event	4	4
Self-Activation or Keying	4	4
Loose or Intermittent Connection	4	4
Pressure Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Noise, Audible	4	4
Device Dislodged or Dislocated	3	3
Inaccurate Delivery	3	3
Appropriate Term/Code Not Available	3	3
Physical Resistance/Sticking	3	3
Unexpected Therapeutic Results	3	3
Connection Problem	3	3
No Display/Image	3	3
Deflation Problem	3	3
Moisture or Humidity Problem	3	3
Disconnection	3	3
Unintended Ejection	3	3
Component Missing	3	3
Explosion	2	2
Protective Measures Problem	2	2
Unintended System Motion	2	2
Tear, Rip or Hole in Device Packaging	2	2
Complete Loss of Power	2	2
Failure to Deflate	2	2
Display or Visual Feedback Problem	2	2
Material Deformation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	288	296
Air Embolism	178	179
Insufficient Information	64	64
Cardiac Arrest	34	35
Extravasation	25	25
No Patient Involvement	18	18
No Known Impact Or Consequence To Patient	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Infiltration into Tissue	8	8
Respiratory Failure	7	7
Low Blood Pressure/ Hypotension	7	7
Vascular Dissection	7	7
Embolism/Embolus	7	7
Respiratory Arrest	6	6
Chest Pain	5	5
Chemical Exposure	4	4
Death	3	3
Electric Shock	3	3
No Consequences Or Impact To Patient	3	3
Unspecified Tissue Injury	3	3
Ischemia Stroke	2	2
Arrhythmia	2	2
Stroke/CVA	2	2
Ventilator Dependent	2	2
Diaphoresis	2	2
Myocardial Infarction	2	2
Aneurysm	2	2
Ventricular Fibrillation	2	2
Low Oxygen Saturation	1	1
Hemorrhage/Bleeding	1	1
Underdose	1	1
Great Vessel Perforation	1	1
Blurred Vision	1	1
Vitreous Floaters	1	1
Swelling/ Edema	1	1
Cough	1	1
Eye Injury	1	1
Renal Impairment	1	1
Pain	1	1
Fall	1	1
Dyspnea	1	1
Numbness	1	1
Injury	1	1
Chills	1	1
Angina	1	1
Overdose	1	1
Obstruction/Occlusion	1	1
Rupture	1	1
Diminished Pulse Pressure	1	1
Ischemic Heart Disease	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