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
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	35	35
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
Air/Gas in Device	13	13
Defective Device	13	13
Leak/Splash	11	11
Use of Device Problem	10	10
Output Problem	8	8
Mechanical Problem	8	8
Therapeutic or Diagnostic Output Failure	7	7
Product Quality Problem	7	7
Device Contaminated During Manufacture or Shipping	7	7
Device Contamination with Chemical or Other Material	7	7
Improper or Incorrect Procedure or Method	5	5
Separation Failure	5	5
Self-Activation or Keying	5	5
Material Integrity Problem	5	5
Inaccurate Delivery	4	4
Particulates	4	4
Appropriate Term/Code Not Available	4	4
Defective Component	4	4
No Apparent Adverse Event	4	4
Protective Measures Problem	3	3
Physical Resistance/Sticking	3	3
Display or Visual Feedback Problem	3	3
Material Separation	3	3
Unexpected Therapeutic Results	3	3
Material Disintegration	3	3
Component Missing	3	3
Device Fell	3	3
Unsealed Device Packaging	3	3
Pressure Problem	3	3
Deflation Problem	3	3
Disconnection	3	3
Thermal Decomposition of Device	2	2
Improper Flow or Infusion	2	2
Connection Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Explosion	2	2
Device Difficult to Setup or Prepare	2	2
Unintended Ejection	2	2
Backflow	2	2
Failure to Deliver	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	245	248
Air Embolism	164	165
Insufficient Information	58	58
No Patient Involvement	54	54
No Known Impact Or Consequence To Patient	42	42
Cardiac Arrest	33	33
Extravasation	26	26
Not Applicable	15	15
Vascular Dissection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Low Blood Pressure/ Hypotension	8	8
Infiltration into Tissue	8	8
Respiratory Failure	7	7
Death	7	7
No Consequences Or Impact To Patient	7	7
Respiratory Arrest	6	6
Embolism/Embolus	6	6
Embolism	5	5
Chest Pain	5	5
Chemical Exposure	5	5
Ventricular Fibrillation	4	4
Electric Shock	3	3
Unspecified Tissue Injury	3	3
Ischemia Stroke	2	2
Arrhythmia	2	2
Myocardial Infarction	2	2
Aneurysm	2	2
Diaphoresis	2	2
Non specific EKG/ECG Changes	1	1
Ventilator Dependent	1	1
Hemorrhage/Bleeding	1	1
Hypersensitivity/Allergic reaction	1	1
Thromboembolism	1	1
Great Vessel Perforation	1	1
Underdose	1	1
Stroke/CVA	1	1
Cough	1	1
Swelling/ Edema	1	1
No Code Available	1	1
Eye Injury	1	1
Dyspnea	1	1
Fall	1	1
Renal Impairment	1	1
Pain	1	1
Cardiopulmonary Arrest	1	1
Nausea	1	1
Brain Injury	1	1
Angina	1	1
Chills	1	1
Injury	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