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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
Product CodeMPB
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 120 120
2019 119 119
2020 179 179
2021 192 192
2022 166 166

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 144 144
Break 76 76
Difficult to Remove 63 63
Material Deformation 63 63
Product Quality Problem 58 58
Fluid/Blood Leak 52 52
Material Frayed 44 44
Deformation Due to Compressive Stress 42 42
Crack 34 34
Unraveled Material 30 30
Physical Resistance/Sticking 30 30
Leak/Splash 28 28
Migration or Expulsion of Device 22 22
Adverse Event Without Identified Device or Use Problem 19 19
Detachment of Device or Device Component 16 16
Material Integrity Problem 14 14
Material Twisted/Bent 13 13
Infusion or Flow Problem 12 12
Obstruction of Flow 12 12
Migration 10 10
Material Separation 9 9
Difficult to Insert 9 9
Disconnection 8 8
Difficult to Advance 8 8
Gas/Air Leak 8 8
Device Handling Problem 6 6
Device Damaged Prior to Use 6 6
Defective Component 6 6
Component Incompatible 6 6
Loose or Intermittent Connection 6 6
Kinked 5 5
Failure to Advance 5 5
Device Markings/Labelling Problem 5 5
Material Split, Cut or Torn 5 5
Air/Gas in Device 4 4
Device Operates Differently Than Expected 4 4
Contamination /Decontamination Problem 4 4
Physical Resistance 3 3
Malposition of Device 3 3
Device Dislodged or Dislocated 3 3
Material Rupture 3 3
Device Slipped 3 3
Suction Failure 3 3
Separation Problem 3 3
Material Distortion 3 3
Appropriate Term/Code Not Available 3 3
Insufficient Information 2 2
Protective Measures Problem 2 2
Mechanics Altered 2 2
Sticking 2 2
Suction Problem 2 2
Insufficient Flow or Under Infusion 2 2
Device Contamination with Chemical or Other Material 2 2
Aspiration Issue 2 2
Failure to Infuse 2 2
Tear, Rip or Hole in Device Packaging 2 2
Connection Problem 2 2
Hole In Material 2 2
Delivered as Unsterile Product 2 2
Retraction Problem 2 2
Contamination 2 2
Complete Blockage 2 2
Bent 2 2
Material Fragmentation 2 2
Entrapment of Device 2 2
Unintended Ejection 1 1
Display or Visual Feedback Problem 1 1
Positioning Failure 1 1
Backflow 1 1
Air Leak 1 1
Failure To Adhere Or Bond 1 1
Occlusion Within Device 1 1
Unsealed Device Packaging 1 1
Nonstandard Device 1 1
Mechanical Problem 1 1
Melted 1 1
Activation, Positioning or Separation Problem 1 1
Dull, Blunt 1 1
Expulsion 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Fitting Problem 1 1
Material Perforation 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Uncoiled 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Component Missing 1 1
Volume Accuracy Problem 1 1
No Flow 1 1
Pumping Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Fail-Safe Did Not Operate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 306 306
No Consequences Or Impact To Patient 219 219
No Known Impact Or Consequence To Patient 65 65
Insufficient Information 54 54
No Patient Involvement 34 34
No Information 31 31
Blood Loss 23 23
No Code Available 19 19
Needle Stick/Puncture 18 18
Foreign Body In Patient 12 12
Hemorrhage/Bleeding 12 12
Hematoma 6 6
Radiation Exposure, Unintended 6 6
Unintended Radiation Exposure 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Death 3 3
Device Embedded In Tissue or Plaque 3 3
Pain 3 3
Air Embolism 3 3
Erythema 2 2
Decreased Respiratory Rate 2 2
Cardiac Arrest 2 2
Headache 2 2
Swelling/ Edema 2 2
Exsanguination 2 2
Low Blood Pressure/ Hypotension 2 2
Loss of consciousness 2 2
Low Oxygen Saturation 2 2
Skin Tears 2 2
Abrasion 1 1
Asystole 1 1
Bacterial Infection 1 1
Overdose 1 1
Hemothorax 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Pneumonia 1 1
Pneumothorax 1 1
Dizziness 1 1
Injury 1 1
Fever 1 1
Failure of Implant 1 1
Perforation 1 1
Thrombus 1 1
Perforation of Vessels 1 1
Anemia 1 1
Cardiopulmonary Arrest 1 1
Neck Pain 1 1
Reaction, Injection Site 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 Medical Components, Inc dba MedComp II Aug-25-2018
4 Medtronic Minimally Invasive Therapies Group II Mar-14-2018
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