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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, fistula
Regulation Description Blood access device and accessories.
Product CodeFIE
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
DIMESOL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 21 21
2017 11 11
2018 12 12
2019 21 21
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Device Dislodged or Dislocated 20 20
Disconnection 6 6
Expulsion 5 5
Detachment of Device or Device Component 5 5
Fluid Leak 4 4
Migration or Expulsion of Device 3 3
Unintended Movement 3 3
Detachment Of Device Component 2 2
Leak/Splash 2 2
Material Separation 2 2
Break 2 2
Use of Device Problem 2 2
Device Operational Issue 2 2
No Apparent Adverse Event 2 2
Insufficient Information 1 1
Inadequate User Interface 1 1
Device Operates Differently Than Expected 1 1
Crack 1 1
Unintended Ejection 1 1
Tube 1 1
Air Leak 1 1
Device Slipped 1 1
Hole In Material 1 1
Mechanical Problem 1 1
Loose or Intermittent Connection 1 1
Defective Component 1 1
Connection Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination 1 1
Fail-Safe Did Not Operate 1 1
Backflow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blood Loss 28 28
Hemolysis 14 14
Hypovolemia 12 12
Loss of consciousness 12 12
Low Blood Pressure/ Hypotension 9 9
Exsanguination 6 6
Death 6 6
Cardiopulmonary Arrest 5 5
No Known Impact Or Consequence To Patient 5 5
Not Applicable 4 4
Hemorrhage/Bleeding 4 4
Cardiac Arrest 4 4
Chest Pain 3 3
Pain 3 3
Needle Stick/Puncture 2 2
Myocardial Infarction 2 2
Anemia 2 2
Abrasion 1 1
Infiltration into Tissue 1 1
Skin Discoloration 1 1
Sweating 1 1
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Lethargy 1 1
Nausea 1 1
Laceration(s) 1 1
Coagulation Disorder 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Chest Tightness/Pressure 1 1
Suture Abrasion 1 1
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Shock 1 1
Vomiting 1 1
Dizziness 1 1
Post Operative Wound Infection 1 1
No Information 1 1

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