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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 173 173

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 175 175
Material Deformation 100 100
Break 88 88
Material Frayed 76 76
Difficult to Remove 76 76
Product Quality Problem 72 72
Deformation Due to Compressive Stress 66 66
Fluid/Blood Leak 65 65
Unraveled Material 46 46
Material Twisted/Bent 41 41
Physical Resistance/Sticking 40 40
Crack 40 40
Obstruction of Flow 34 34
Leak/Splash 27 27
Material Separation 23 23
Detachment of Device or Device Component 21 21
Migration or Expulsion of Device 21 21
Component Incompatible 20 20
Adverse Event Without Identified Device or Use Problem 18 18
Migration 17 17
Defective Component 17 17
Material Integrity Problem 15 15
Disconnection 13 13
Infusion or Flow Problem 12 12
Insufficient Flow or Under Infusion 10 10
Device Markings/Labelling Problem 9 9
Failure to Infuse 9 9
Contamination /Decontamination 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
Material Split, Cut or Torn 6 6
Device Handling Problem 6 6
Insufficient Information 5 5
Air/Gas in Device 5 5
Material Fragmentation 5 5
Failure to Advance 4 4
Loose or Intermittent Connection 4 4
Fitting Problem 4 4
Separation Problem 4 4
Suction Failure 3 3
Output Problem 3 3
Suction Problem 3 3
Unintended Ejection 3 3
Malposition of Device 3 3
Mechanical Problem 3 3
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Tear, Rip or Hole in Device Packaging 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 616 616
No Consequences Or Impact To Patient 180 180
Insufficient Information 97 97
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
Unspecified Infection 3 3
Death 3 3
Device Embedded In Tissue or Plaque 3 3
Failure of Implant 3 3
Cardiac Arrest 3 3
Pain 3 3
Exsanguination 2 2
Decreased Respiratory Rate 2 2
Low Oxygen Saturation 2 2
Loss of consciousness 2 2
Fever 2 2
Thrombosis/Thrombus 2 2
Headache 2 2
Erythema 2 2
Skin Tears 2 2
Bradycardia 2 2
Thrombus 1 1
Hemothorax 1 1
Bacterial Infection 1 1
Hypoxia 1 1
Perforation of Vessels 1 1
Asystole 1 1
Pneumonia 1 1
Laceration(s) 1 1
Alteration in Body Temperature 1 1
Discomfort 1 1
Neck Pain 1 1
Chills 1 1
Burning Sensation 1 1
Peritonitis 1 1
Overdose 1 1
Abrasion 1 1

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