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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device injector and syringe, angiographic
Regulation Description Angiographic injector and syringe.
Product CodeDXT
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, 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 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
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 188 188
Insufficient Information 33 33
Manufacturing, Packaging or Shipping Problem 32 32
Break 29 29
Detachment of Device or Device Component 18 18
Activation Problem 17 17
Air/Gas in Device 13 13
Fluid/Blood Leak 13 16
Defective Device 11 11
Inflation Problem 10 10
Contamination /Decontamination Problem 10 10
Gas/Air Leak 8 8
Mechanical Problem 7 7
Leak/Splash 7 7
Use of Device Problem 7 7
Output Problem 7 7
Therapeutic or Diagnostic Output Failure 6 6
Separation Failure 4 4
Self-Activation or Keying 4 4
Defective Component 4 4
No Apparent Adverse Event 4 4
Unsealed Device Packaging 3 3
Disconnection 3 3
Physical Resistance/Sticking 3 3
Inaccurate Delivery 3 3
Material Separation 3 3
Component Missing 3 3
Product Quality Problem 3 3
Deflation Problem 3 3
Pressure Problem 3 3
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 3 3
Unexpected Therapeutic Results 3 3
Connection Problem 2 2
Protective Measures Problem 2 2
Improper Flow or Infusion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Displays Incorrect Message 2 2
Unexpected Shutdown 2 2
Display or Visual Feedback Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Entrapment of Device 2 2
Fire 2 2
Material Puncture/Hole 2 2
Material Integrity Problem 2 2
Loose or Intermittent Connection 2 2
Unintended Electrical Shock 2 2
Premature Activation 2 2
Contamination 2 2
Explosion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 251 254
Air Embolism 137 137
Insufficient Information 59 59
Cardiac Arrest 32 32
Extravasation 22 22
No Patient Involvement 18 18
No Known Impact Or Consequence To Patient 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Infiltration into Tissue 8 8
Low Blood Pressure/ Hypotension 7 7
Vascular Dissection 7 7
Respiratory Failure 7 7
Respiratory Arrest 6 6
Embolism/Embolus 6 6
Chest Pain 5 5
Chemical Exposure 4 4
No Consequences Or Impact To Patient 3 3
Death 3 3
Unspecified Tissue Injury 3 3
Electric Shock 3 3
Ventricular Fibrillation 2 2
Diaphoresis 2 2
Aneurysm 2 2
Arrhythmia 2 2
Ischemia Stroke 2 2
Myocardial Infarction 2 2
Rupture 1 1
Ischemic Heart Disease 1 1
Angina 1 1
Swelling/ Edema 1 1
Cough 1 1
Chills 1 1
Injury 1 1
Great Vessel Perforation 1 1
Underdose 1 1
Malaise 1 1
Ventilator Dependent 1 1
Hemorrhage/Bleeding 1 1
Perforation 1 1
Hypersensitivity/Allergic reaction 1 1
Pain 1 1
Overdose 1 1
Ischemia 1 1
Dyspnea 1 1
Eye Injury 1 1
Diminished Pulse Pressure 1 1
Vasoconstriction 1 1
Renal Impairment 1 1
Non specific EKG/ECG Changes 1 1
Stroke/CVA 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 LeMaitre Vascular, Inc. II May-04-2021
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 Merit Medical Systems, Inc. II Oct-11-2024
7 Merit Medical Systems, Inc. II Oct-11-2024
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