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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 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
2019 119 119
2020 179 179
2021 192 192
2022 166 166
2023 203 203
2024 145 145

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 173 173
Material Deformation 95 95
Break 86 86
Material Frayed 76 76
Difficult to Remove 75 75
Product Quality Problem 69 69
Deformation Due to Compressive Stress 66 66
Fluid/Blood Leak 63 63
Unraveled Material 45 45
Physical Resistance/Sticking 40 40
Crack 39 39
Material Twisted/Bent 35 35
Obstruction of Flow 30 30
Leak/Splash 27 27
Migration or Expulsion of Device 21 21
Material Separation 21 21
Component Incompatible 20 20
Detachment of Device or Device Component 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Defective Component 17 17
Migration 17 17
Material Integrity Problem 15 15
Disconnection 13 13
Infusion or Flow Problem 12 12
Insufficient Flow or Under Infusion 10 10
Contamination /Decontamination Problem 9 9
Failure to Infuse 9 9
Device Markings/Labelling Problem 9 9
Difficult to Advance 8 8
Gas/Air Leak 8 8
Difficult to Insert 7 7
Device Damaged Prior to Use 6 6
Device Handling Problem 6 6
Insufficient Information 5 5
Air/Gas in Device 5 5
Material Fragmentation 5 5
Material Split, Cut or Torn 5 5
Failure to Advance 4 4
Separation Problem 4 4
Loose or Intermittent Connection 4 4
Fitting Problem 4 4
Suction Failure 3 3
Suction Problem 3 3
Unintended Ejection 3 3
Malposition of Device 3 3
Mechanical Problem 3 3
Device Contamination with Chemical or Other Material 2 2
Device Dislodged or Dislocated 2 2
Tear, Rip or Hole in Device Packaging 2 2
Connection Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 592 592
No Consequences Or Impact To Patient 180 180
Insufficient Information 93 93
No Patient Involvement 29 29
No Known Impact Or Consequence To Patient 24 24
Hemorrhage/Bleeding 21 21
No Information 20 20
Foreign Body In Patient 16 16
Needle Stick/Puncture 14 14
Blood Loss 13 13
Hematoma 9 9
Unintended Radiation Exposure 8 8
No Code Available 8 8
Air Embolism 6 6
Radiation Exposure, Unintended 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Low Blood Pressure/ Hypotension 4 4
Swelling/ Edema 4 4
Device Embedded In Tissue or Plaque 3 3
Cardiac Arrest 3 3
Failure of Implant 3 3
Death 3 3
Thrombosis/Thrombus 2 2
Erythema 2 2
Exsanguination 2 2
Pain 2 2
Bradycardia 2 2
Skin Tears 2 2
Headache 2 2
Loss of consciousness 2 2
Low Oxygen Saturation 2 2
Decreased Respiratory Rate 2 2
Unspecified Infection 2 2
Abrasion 1 1
Overdose 1 1
Peritonitis 1 1
Embolism/Embolus 1 1
Perforation 1 1
Fever 1 1
Burning Sensation 1 1
Neck Pain 1 1
Ischemia 1 1
Discomfort 1 1
Alteration in Body Temperature 1 1
Laceration(s) 1 1
Pneumonia 1 1
Asystole 1 1
Dizziness 1 1
Perforation of Vessels 1 1
Hypoxia 1 1

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