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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, peritoneal, long-term indwelling
Regulation Description Peritoneal dialysis system and accessories.
Product CodeFJS
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213602  Argyle Peritoneal Dialysis Cathetor and Kit, Ritus ...

MDR Year MDR Reports MDR Events
2020 94 94
2021 78 78
2022 102 106
2023 619 619
2024 149 149
2025 141 141

Device Problems MDRs with this Device Problem Events in those MDRs
Break 228 228
Adverse Event Without Identified Device or Use Problem 142 142
Migration 107 107
Insufficient Information 64 64
Malposition of Device 63 63
Obstruction of Flow 62 62
Appropriate Term/Code Not Available 58 58
Product Quality Problem 58 58
Connection Problem 47 47
Insufficient Flow or Under Infusion 45 45
Material Puncture/Hole 44 44
Improper or Incorrect Procedure or Method 40 40
Infusion or Flow Problem 39 39
Detachment of Device or Device Component 32 32
Migration or Expulsion of Device 30 30
Fluid/Blood Leak 27 27
Positioning Problem 25 25
Complete Blockage 22 22
Leak/Splash 19 19
Improper Flow or Infusion 18 18
Output Problem 14 14
Fracture 12 12
Defective Component 12 12
Patient Device Interaction Problem 12 12
Therapeutic or Diagnostic Output Failure 12 12
Microbial Contamination of Device 11 11
Material Split, Cut or Torn 9 9
Contamination 9 9
Defective Device 8 12
Crack 7 7
Material Deformation 7 7
Material Twisted/Bent 7 7
Use of Device Problem 7 7
Material Separation 6 6
No Flow 6 6
Protective Measures Problem 5 5
Suction Problem 5 5
Material Frayed 5 5
Contamination /Decontamination Problem 5 5
Material Integrity Problem 5 5
Difficult to Remove 4 4
Failure to Clean Adequately 4 4
Component Missing 4 4
Entrapment of Device 4 4
Partial Blockage 4 4
Inadequate Ultra Filtration 3 3
Material Fragmentation 3 3
Disconnection 3 3
Unintended Movement 3 3
Material Perforation 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 341 345
No Clinical Signs, Symptoms or Conditions 300 300
Peritonitis 206 206
Unspecified Infection 114 114
Abdominal Pain 73 73
Bacterial Infection 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Pain 41 41
Unintended Radiation Exposure 27 27
Foreign Body In Patient 20 20
No Consequences Or Impact To Patient 20 20
Fungal Infection 19 19
No Information 19 19
Failure of Implant 16 16
Hemorrhage/Bleeding 14 14
Fever 14 14
Thrombosis/Thrombus 13 13
Swelling/ Edema 13 13
Sepsis 12 12
Erythema 9 9
Constipation 9 9
Device Embedded In Tissue or Plaque 8 8
Hypervolemia 8 8
Vomiting 8 8
Hernia 8 8
Discomfort 8 8
Dyspnea 7 7
Adhesion(s) 7 7
Death 6 6
Nausea 6 6
Cardiac Arrest 5 5
Inflammation 5 5
Chills 5 5
Hematoma 4 4
No Code Available 4 4
Chest Pain 4 4
Obstruction/Occlusion 4 4
Abscess 4 4
Injury 3 3
Urinary Retention 3 3
No Known Impact Or Consequence To Patient 3 3
Thrombosis 3 3
Bradycardia 3 3
Itching Sensation 3 3
Purulent Discharge 3 3
Perforation of Vessels 3 3
Cough 3 3
Abdominal Distention 3 3
Low Blood Pressure/ Hypotension 3 3
Hypersensitivity/Allergic reaction 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Apr-07-2023
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