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TPLC
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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
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
1. K232388
High Pressure Tubing
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
MDR Year
MDR Reports
MDR Events
2019
121
121
2020
93
93
2021
132
132
2022
111
114
2023
117
117
2024
118
118
2025
9
9
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
37
37
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
Defective Device
13
13
Air/Gas in Device
13
13
Leak/Splash
11
11
Use of Device Problem
10
10
Mechanical Problem
8
8
Output Problem
8
8
Device Contamination with Chemical or Other Material
7
7
Therapeutic or Diagnostic Output Failure
7
7
Device Contaminated During Manufacture or Shipping
7
7
Product Quality Problem
7
7
Self-Activation or Keying
5
5
Separation Failure
5
5
Material Integrity Problem
5
5
Improper or Incorrect Procedure or Method
5
5
No Apparent Adverse Event
4
4
Defective Component
4
4
Inaccurate Delivery
4
4
Particulates
4
4
Appropriate Term/Code Not Available
4
4
Protective Measures Problem
3
3
Disconnection
3
3
Physical Resistance/Sticking
3
3
Display or Visual Feedback Problem
3
3
Material Disintegration
3
3
Component Missing
3
3
Unexpected Therapeutic Results
3
3
Deflation Problem
3
3
Unsealed Device Packaging
3
3
Pressure Problem
3
3
Material Separation
3
3
Device Fell
3
3
Connection Problem
2
2
Unintended Electrical Shock
2
2
Material Puncture/Hole
2
2
Tear, Rip or Hole in Device Packaging
2
2
Thermal Decomposition of Device
2
2
Unexpected Shutdown
2
2
Premature Activation
2
2
Contamination
2
2
Device Displays Incorrect Message
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
251
254
Air Embolism
166
167
Insufficient Information
59
59
No Patient Involvement
54
54
No Known Impact Or Consequence To Patient
42
42
Cardiac Arrest
34
34
Extravasation
26
26
Not Applicable
15
15
Vascular Dissection
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Infiltration into Tissue
8
8
Low Blood Pressure/ Hypotension
8
8
No Consequences Or Impact To Patient
7
7
Death
7
7
Respiratory Failure
7
7
Respiratory Arrest
6
6
Embolism/Embolus
6
6
Embolism
5
5
Chemical Exposure
5
5
Chest Pain
5
5
Ventricular Fibrillation
4
4
Unspecified Tissue Injury
3
3
Electric Shock
3
3
Aneurysm
2
2
Diaphoresis
2
2
Ischemia Stroke
2
2
Arrhythmia
2
2
Myocardial Infarction
2
2
Rupture
1
1
Transient Ischemic Attack
1
1
Atrial Fibrillation
1
1
Swelling/ Edema
1
1
Cough
1
1
Ischemic Heart Disease
1
1
Ventilator Dependent
1
1
No Code Available
1
1
Underdose
1
1
Renal Impairment
1
1
Pain
1
1
Great Vessel Perforation
1
1
Perforation
1
1
Chills
1
1
Eye Injury
1
1
Hemorrhage/Bleeding
1
1
Ischemia
1
1
Fall
1
1
Angina
1
1
Overdose
1
1
Cardiopulmonary Arrest
1
1
Aortic Dissection
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
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