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
BAYER MEDICAL CARE, INC.
	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
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	211	211
Insufficient Information	51	51
Break	29	33
Manufacturing, Packaging or Shipping Problem	25	25
Connection Problem	24	24
Loose or Intermittent Connection	22	22
Air/Gas in Device	16	17
Activation Problem	16	16
Detachment of Device or Device Component	14	14
Defective Device	11	11
Fluid/Blood Leak	9	12
Use of Device Problem	8	8
Leak/Splash	7	7
Product Quality Problem	7	7
Output Problem	7	7
Contamination /Decontamination Problem	5	5
Unintended Movement	5	5
Contamination	4	8
Inflation Problem	4	4
Unsealed Device Packaging	4	4
Separation Failure	4	4
Material Separation	4	4
No Apparent Adverse Event	4	4
Mechanical Problem	4	4
Self-Activation or Keying	4	4
Noise, Audible	4	4
Device Dislodged or Dislocated	3	3
Physical Resistance/Sticking	3	3
Unexpected Therapeutic Results	3	3
No Display/Image	3	3
Defective Component	3	3
Therapeutic or Diagnostic Output Failure	3	3
Pressure Problem	3	3
Moisture or Humidity Problem	3	3
Component Missing	3	3
Improper or Incorrect Procedure or Method	3	3
Unintended Ejection	3	3
Explosion	2	2
Inaccurate Delivery	2	2
Tear, Rip or Hole in Device Packaging	2	2
Protective Measures Problem	2	2
Unintended System Motion	2	2
Material Deformation	2	2
Complete Loss of Power	2	2
Failure to Deflate	2	2
Display or Visual Feedback Problem	2	2
Premature Activation	2	2
Device Difficult to Setup or Prepare	2	2
Backflow	2	2
Circuit Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	314	322
Air Embolism	167	168
Insufficient Information	62	62
Cardiac Arrest	31	32
Extravasation	19	19
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
Embolism/Embolus	6	6
Respiratory Arrest	6	6
Vascular Dissection	5	5
Electric Shock	3	3
Chemical Exposure	3	3
Unspecified Tissue Injury	3	3
Ischemia Stroke	2	2
Diaphoresis	2	2
Myocardial Infarction	2	2
Stroke/CVA	2	2
Chest Pain	2	2
Arrhythmia	2	2
Pulmonary Embolism	1	1
Aneurysm	1	1
Angina	1	1
Dyspnea	1	1
Non specific EKG/ECG Changes	1	1
Pain	1	1
Perforation	1	1
Vasoconstriction	1	1
Ventricular Fibrillation	1	1
Blurred Vision	1	1
Great Vessel Perforation	1	1
Chills	1	1
Dizziness	1	1
Brain Injury	1	2
Ventilator Dependent	1	1
Numbness	1	1
Obstruction/Occlusion	1	1
Low Oxygen Saturation	1	1
Ischemic Heart Disease	1	1
Eye Injury	1	1
Fall	1	1
Vitreous Floaters	1	1
Bone Fracture(s)	1	1
Hemorrhage/Bleeding	1	1
Diminished Pulse Pressure	1	1
Renal Impairment	1	1
Cough	1	1
Swelling/ Edema	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	LeMaitre Vascular, Inc.	II	May-04-2021
4	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
5	Merit Medical Systems, Inc.	II	Oct-11-2024
6	Merit Medical Systems, Inc.	II	Oct-11-2024