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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, hemodialysis, non-implanted
Regulation Description Blood access device and accessories.
Product CodeMPB
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

MDR Year MDR Reports MDR Events
2015 51 51
2016 70 70
2017 86 86
2018 120 120
2019 118 118
2020 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Break 68 68
Material Puncture/Hole 45 45
Kinked 45 45
Material Deformation 44 44
Fluid Leak 42 42
Difficult to Remove 39 39
Unraveled Material 38 38
Product Quality Problem 33 33
Material Frayed 28 28
Physical Resistance 27 27
Crack 26 26
Leak/Splash 24 24
Physical Resistance/Sticking 22 22
Guidewire 19 19
Migration or Expulsion of Device 17 17
Catheter 15 15
Device Operates Differently Than Expected 14 14
Material Integrity Problem 14 14
Detachment of Device or Device Component 12 12
Infusion or Flow Problem 10 10
Tip 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Sticking 10 10
Material Twisted/Bent 9 9
Material Separation 9 9
Appropriate Term/Code Not Available 8 8
Loose or Intermittent Connection 8 8
Device Damaged Prior to Use 8 8
Failure to Advance 8 8
Difficult to Insert 7 7
Wire 7 7
Device Handling Problem 7 7
Bent 7 7
Hole In Material 6 6
Fracture 6 6
Difficult to Advance 6 6
Disconnection 5 5
Delivered as Unsterile Product 5 5
Adapter (Adaptor) 5 5
Clamp 5 5
Retraction Problem 5 5
Split 5 5
Deformation Due to Compressive Stress 5 5
Needle 5 5
Material Split, Cut or Torn 4 4
Device Slipped 4 4
Hub 4 4
Safety Interlock 4 4
Entrapment of Device 3 3
Occlusion Within Device 3 3
Material Rupture 3 3
Improper or Incorrect Procedure or Method 3 3
Material Distortion 3 3
Device Markings/Labelling Problem 3 3
Malposition of Device 3 3
Mechanics Altered 3 3
Device Contamination with Chemical or Other Material 3 3
Obstruction of Flow 3 3
Collapse 3 3
Device Dislodged or Dislocated 3 3
Gas Leak 2 2
Protective Measures Problem 2 2
Component Missing 2 2
Device Issue 2 2
Aspiration Issue 2 2
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Guide 2 2
Fail-Safe Problem 2 2
Defective Component 2 2
Device Inoperable 2 2
Partial Blockage 2 2
Shaft 2 2
Syringe 1 1
Failure To Adhere Or Bond 1 1
Backflow 1 1
Port 1 1
Y-Piece Connector 1 1
Coil 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Connector 1 1
Failure to Infuse 1 1
Dull, Blunt 1 1
Fitting Problem 1 1
Volume Accuracy Problem 1 1
Output below Specifications 1 1
Positioning Problem 1 1
Migration 1 1
Failure to Disconnect 1 1
Fail-Safe Did Not Operate 1 1
Separation Failure 1 1
Cut In Material 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Uncoiled 1 1
Material Perforation 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 261 261
No Known Impact Or Consequence To Patient 139 139
No Information 56 56
No Patient Involvement 37 37
Blood Loss 33 33
Needle Stick/Puncture 23 23
No Code Available 20 20
Radiation Exposure, Unintended 6 6
Hemorrhage/Bleeding 6 6
Device Embedded In Tissue or Plaque 5 5
Foreign Body In Patient 4 4
Death 4 4
Air Embolism 4 4
Injury 3 3
Pain 3 3
Headache 3 3
Anemia 2 2
Cardiopulmonary Arrest 2 2
Low Blood Pressure/ Hypotension 2 2
Perforation 2 2
Skin Tears 2 2
Reaction, Injection Site 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Low Oxygen Saturation 1 1
Cardiac Tamponade 1 1
Peritonitis 1 1
Abrasion 1 1
Insufficient Information 1 1
Increased Sensitivity 1 1
Skin Irritation 1 1
Hypovolemic Shock 1 1
Occlusion 1 1
Exsanguination 1 1
Hematoma 1 1
Test Result 1 1
Vomiting 1 1
Dizziness 1 1
Cardiogenic Shock 1 1
Reaction 1 1
Fistula 1 1
Hemothorax 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Overdose 1 1
Abdominal Pain 1 1
Apnea 1 1
Cardiac Arrest 1 1
Coagulation Disorder 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Apr-10-2018
2 Arrow International Inc II Feb-20-2018
3 Arrow International Inc II Jun-12-2017
4 Cordis Corporation II Aug-18-2015
5 Medical Components, Inc dba MedComp II Aug-25-2018
6 Medtronic Minimally Invasive Therapies Group II Mar-14-2018
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