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
FORTIS BIOSOLUTIONS COMPANY LIMITED
	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	2
SHENZHEN BOON MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN MAIWEI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	225	225
Insufficient Device Problem Information	57	57
Loose or Intermittent Connection	34	34
Connection Problem	33	33
Manufacturing, Packaging or Shipping Problem	22	22
Activation Problem	15	15
Detachment of Device or Device Component	8	8
Air/Gas in Device	5	5
Unintended Movement	5	5
Fluid/Blood Leak	4	7
Inflation Problem	4	4
Use of Device Problem	4	4
Leak/Splash	4	4
No Apparent Adverse Event	4	4
Unsealed Device Packaging	4	4
Contamination /Decontamination Problem	4	4
Break	3	3
Mechanical Problem	3	3
Product Quality Problem	3	3
Material Separation	3	3
Device Dislodged or Dislocated	3	3
Moisture or Humidity Problem	3	3
Unintended Electrical Shock	2	2
Failure to Deflate	2	2
Circuit Failure	2	2
Complete Loss of Power	2	2
Deflation Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Tear, Rip or Hole in Device Packaging	2	2
Self-Activation or Keying	2	2
Device Contaminated During Manufacture or Shipping	2	2
Unexpected Shutdown	1	1
Device Fell	1	1
Physical Resistance/Sticking	1	1
Component Misassembled	1	1
Device Handling Problem	1	1
Temperature Problem	1	1
Pressure Problem	1	1
Packaging Problem	1	1
Material Integrity Problem	1	1
Material Deformation	1	1
Difficult to Open or Close	1	1
Device Markings/Labelling Problem	1	2
Failure to Pump	1	1
Off-Label Use	1	1
Overheating of Device	1	1
Unintended System Motion	1	1
Electrostatic Discharge	1	1
Fracture	1	1
Difficult to Flush	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	339	347
Air Embolism	181	182
Insufficient Information	68	68
Cardiac Arrest	31	32
Extravasation	22	22
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Infiltration into Tissue	8	8
Respiratory Failure	7	7
Low Blood Pressure/ Hypotension	7	7
Respiratory Arrest	6	6
Embolism/Embolus	6	6
Vascular Dissection	5	5
Electric Shock	3	3
Unspecified Tissue Injury	3	3
Chemical Exposure	3	3
Chest Pain	2	2
Ischemia Stroke	2	2
Diaphoresis	2	2
Arrhythmia	2	2
Myocardial Infarction	2	2
Stroke/CVA	2	2
Reduced Blood Flow	1	1
Cough	1	1
Low Oxygen Saturation	1	1
Renal Impairment	1	1
Pain	1	1
Hemodynamic instability	1	1
Blurred Vision	1	1
Bone Fracture(s)	1	1
Aneurysm	1	1
Non specific EKG/ECG Changes	1	1
Renal Failure	1	1
Pulmonary Embolism	1	1
Ventricular Fibrillation	1	1
Angina	1	1
Great Vessel Perforation	1	1
Brain Injury	1	2
Perforation	1	1
Eye Injury	1	1
Dyspnea	1	1
Vitreous Floaters	1	1
Dizziness	1	1
Ventilator Dependent	1	1
Obstruction/Occlusion	1	1
Diminished Pulse Pressure	1	1
Vasoconstriction	1	1
Chills	1	1
Fall	1	1
Back pain	1	1
Numbness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B. Braun Medical, Inc.	II	Nov-03-2023
2	Bayer Medical Care, Inc.	II	Jun-03-2026
3	Bayer Medical Care, Inc.	II	Nov-03-2021
4	LeMaitre Vascular, Inc.	II	May-04-2021
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	Medline Industries, LP	II	Apr-17-2026
7	Medline Industries, LP	I	Apr-07-2026
8	Merit Medical Systems, Inc.	II	Oct-11-2024
9	Merit Medical Systems, Inc.	II	Oct-11-2024