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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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New Search show TPLC since Back to Search Results
Device injector and syringe, angiographic
Product CodeDXT
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAYER MEDICAL CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER MEDICAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DIZENGENS MEDICAL SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSPREY MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BOON MEDICAL SUPPLY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 191 191
Manufacturing, Packaging or Shipping Problem 44 44
Detachment of Device or Device Component 32 32
Break 30 30
Insufficient Information 28 28
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
Leak/Splash 11 11
Use of Device Problem 10 10
Air/Gas in Device 10 10
Output Problem 8 8
Mechanical Problem 8 8
Product Quality Problem 7 7
Device Contamination with Chemical or Other Material 7 7
Device Contaminated During Manufacture or Shipping 7 7
Therapeutic or Diagnostic Output Failure 7 7
Separation Failure 5 5
Self-Activation or Keying 5 5
Improper or Incorrect Procedure or Method 5 5
Inaccurate Delivery 4 4
Particulates 4 4
Defective Component 4 4
No Apparent Adverse Event 4 4
Material Integrity Problem 4 4
Pressure Problem 3 3
Protective Measures Problem 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
Component Missing 3 3
Unexpected Therapeutic Results 3 3
Unsealed Device Packaging 3 3
Deflation Problem 3 3
Disconnection 3 3
Material Disintegration 3 3
Display or Visual Feedback Problem 3 3
Entrapment of Device 2 2
No Display/Image 2 2
Thermal Decomposition of Device 2 2
Contamination 2 2
Device Alarm System 2 2
Backflow 2 2
Loss of or Failure to Bond 2 2
Premature Activation 2 2
Device Difficult to Setup or Prepare 2 2
Loose or Intermittent Connection 2 2
Fire 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
Failure to Deliver 2 2
Device Displays Incorrect Message 2 2
Device Markings/Labelling Problem 2 2
Device Fell 2 2
Unintended Electrical Shock 2 2
Material Split, Cut or Torn 2 2
Improper Flow or Infusion 2 2
Inappropriate or Unexpected Reset 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Component Misassembled 1 1
Explosion 1 1
Temperature Problem 1 1
Unexpected Shutdown 1 1
Incomplete or Inadequate Connection 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Failure to Deflate 1 1
Device Sensing Problem 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Flare or Flash 1 1
Free or Unrestricted Flow 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Sparking 1 1
Calibration Problem 1 1
Arcing 1 1
Device Slipped 1 1
Failure to Sense 1 1
Failure to Power Up 1 1
Unable to Obtain Readings 1 1
Difficult to Remove 1 1
Fitting Problem 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Low Readings 1 1
Inaccurate Flow Rate 1 1
Flushing Problem 1 1
Image Display Error/Artifact 1 1
Excess Flow or Over-Infusion 1 1
Failure to Prime 1 1
Off-Label Use 1 1
Unintended System Motion 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 186 189
Air Embolism 145 146
No Patient Involvement 54 54
Insufficient Information 49 49
No Known Impact Or Consequence To Patient 42 42
Cardiac Arrest 30 30
Extravasation 21 21
Not Applicable 15 15
Vascular Dissection 11 11
Infiltration into Tissue 7 7
No Consequences Or Impact To Patient 7 7
Death 7 7
Respiratory Arrest 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Low Blood Pressure/ Hypotension 6 6
Respiratory Failure 6 6
Embolism 5 5
Chemical Exposure 5 5
Embolism/Embolus 4 4
Chest Pain 4 4
Ventricular Fibrillation 4 4
Electric Shock 3 3
Diaphoresis 2 2
Aneurysm 2 2
Unspecified Tissue Injury 2 2
Ischemia Stroke 2 2
Ventilator Dependent 1 1
Eye Injury 1 1
Angina 1 1
Underdose 1 1
Ischemia 1 1
Non specific EKG/ECG Changes 1 1
No Code Available 1 1
Bone Fracture(s) 1 1
Brain Injury 1 1
Arrhythmia 1 1
Nausea 1 1
Diminished Pulse Pressure 1 1
Chills 1 1
Renal Impairment 1 1
Ischemic Heart Disease 1 1
Aortic Dissection 1 1
Abrasion 1 1
Malaise 1 1
Cardiopulmonary Arrest 1 1
Vasoconstriction 1 1
Perforation 1 1
Rupture 1 1
Injury 1 1
Blood Loss 1 1
Suture Abrasion 1 1
Pain 1 1
Atrial Fibrillation 1 1
Transient Ischemic Attack 1 1
Fall 1 1
Hypersensitivity/Allergic reaction 1 1
Thromboembolism 1 1
Overdose 1 1
Myocardial Infarction 1 1
Swelling/ Edema 1 1
Great Vessel Perforation 1 1
Obstruction/Occlusion 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
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