TPLC - Total Product Life Cycle

show TPLC since

Device	injector and syringe, angiographic
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
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
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	214	214
Manufacturing, Packaging or Shipping Problem	44	44
Insufficient Information	35	35
Detachment of Device or Device Component	32	32
Break	30	30
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
Leak/Splash	11	11
Air/Gas in Device	11	11
Use of Device Problem	10	10
Mechanical Problem	8	8
Output Problem	8	8
Device Contaminated During Manufacture or Shipping	7	7
Device Contamination with Chemical or Other Material	7	7
Therapeutic or Diagnostic Output Failure	7	7
Product Quality Problem	7	7
Improper or Incorrect Procedure or Method	5	5
Self-Activation or Keying	5	5
Separation Failure	5	5
Material Integrity Problem	5	5
No Apparent Adverse Event	4	4
Defective Component	4	4
Inaccurate Delivery	4	4
Particulates	4	4
Material Separation	3	3
Unexpected Therapeutic Results	3	3
Component Missing	3	3
Unsealed Device Packaging	3	3
Deflation Problem	3	3
Disconnection	3	3
Material Disintegration	3	3
Display or Visual Feedback Problem	3	3
Appropriate Term/Code Not Available	3	3
Physical Resistance/Sticking	3	3
Pressure Problem	3	3
Protective Measures Problem	3	3
Connection Problem	2	2
Improper Flow or Infusion	2	2
Device Fell	2	2
Unintended Electrical Shock	2	2
Unexpected Shutdown	2	2
Material Split, Cut or Torn	2	2
No Display/Image	2	2
Contamination	2	2
Thermal Decomposition of Device	2	2
Device Alarm System	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	223	226
Air Embolism	159	160
Insufficient Information	56	56
No Patient Involvement	54	54
No Known Impact Or Consequence To Patient	42	42
Cardiac Arrest	32	32
Extravasation	24	24
Not Applicable	15	15
Vascular Dissection	11	11
Low Blood Pressure/ Hypotension	8	8
Infiltration into Tissue	8	8
Death	7	7
No Consequences Or Impact To Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Respiratory Failure	6	6
Respiratory Arrest	6	6
Embolism/Embolus	6	6
Embolism	5	5
Chemical Exposure	5	5
Chest Pain	4	4
Ventricular Fibrillation	4	4
Electric Shock	3	3
Ischemia Stroke	2	2
Diaphoresis	2	2
Myocardial Infarction	2	2
Aneurysm	2	2
Unspecified Tissue Injury	2	2
Ventilator Dependent	1	1
Thromboembolism	1	1
Hemorrhage/Bleeding	1	1
Underdose	1	1
Great Vessel Perforation	1	1
Swelling/ Edema	1	1
Eye Injury	1	1
Renal Impairment	1	1
Pain	1	1
Fall	1	1
Cardiopulmonary Arrest	1	1
Injury	1	1
Chills	1	1
Angina	1	1
Aortic Dissection	1	1
Transient Ischemic Attack	1	1
Overdose	1	1
Blood Loss	1	1
Suture Abrasion	1	1
Obstruction/Occlusion	1	1
Rupture	1	1
Atrial Fibrillation	1	1
Abrasion	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