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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
Product CodeFJS
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 53 53
2020 94 94
2021 78 78
2022 102 102
2023 621 621
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Break 185 185
Adverse Event Without Identified Device or Use Problem 114 114
Product Quality Problem 70 70
Malposition of Device 62 62
Obstruction of Flow 58 58
Insufficient Information 58 58
Appropriate Term/Code Not Available 58 58
Connection Problem 41 41
Material Puncture/Hole 41 41
Migration or Expulsion of Device 40 40
Infusion or Flow Problem 40 40
Improper or Incorrect Procedure or Method 34 34
Fluid/Blood Leak 31 31
Migration 31 31
Positioning Problem 25 25
Insufficient Flow or Under Infusion 25 25
Detachment of Device or Device Component 23 23
Complete Blockage 21 21
Improper Flow or Infusion 18 18
Leak/Splash 16 16
Defective Component 12 12
Microbial Contamination of Device 12 12
Therapeutic or Diagnostic Output Failure 10 10
Material Split, Cut or Torn 9 9
Contamination 9 9
Fracture 8 8
Material Twisted/Bent 8 8
Crack 7 7
No Flow 6 6
Output Problem 6 6
Material Integrity Problem 6 6
Defective Device 6 6
Material Deformation 5 5
Contamination /Decontamination Problem 5 5
Material Frayed 5 5
Suction Problem 5 5
Material Separation 5 5
Use of Device Problem 4 4
Difficult to Remove 4 4
Partial Blockage 4 4
Entrapment of Device 4 4
Component Missing 4 4
Material Perforation 4 4
Failure to Clean Adequately 4 4
Patient Device Interaction Problem 3 3
Unintended Movement 3 3
Device Contamination with Chemical or Other Material 3 3
Protective Measures Problem 3 3
Disconnection 3 3
Inadequate Ultra Filtration 3 3
Flushing Problem 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Material Fragmentation 2 2
Gas/Air Leak 2 2
Device Displays Incorrect Message 2 2
Patient-Device Incompatibility 2 2
Device Dislodged or Dislocated 2 2
Physical Resistance/Sticking 2 2
Device Fell 2 2
Separation Problem 1 1
Data Problem 1 1
Noise, Audible 1 1
Filtration Problem 1 1
Difficult to Advance 1 1
Device Damaged Prior to Use 1 1
Failure to Advance 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Scratched Material 1 1
Power Problem 1 1
Difficult to Flush 1 1
Excess Flow or Over-Infusion 1 1
Restricted Flow rate 1 1
Biofilm coating in Device 1 1
Material Rupture 1 1
Misassembled 1 1
Misconnection 1 1
Moisture Damage 1 1
Unraveled Material 1 1
Short Fill 1 1
Device Slipped 1 1
Volume Accuracy Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 254 254
No Clinical Signs, Symptoms or Conditions 204 204
Peritonitis 193 193
Unspecified Infection 107 107
Abdominal Pain 59 59
Bacterial Infection 53 53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Pain 37 37
No Consequences Or Impact To Patient 37 37
No Information 25 25
Unintended Radiation Exposure 21 21
Failure of Implant 16 16
Fungal Infection 14 14
Fever 13 13
Foreign Body In Patient 13 13
Hemorrhage/Bleeding 12 12
Thrombosis/Thrombus 11 11
Swelling/ Edema 11 11
Sepsis 10 10
Vomiting 8 8
Death 8 8
No Code Available 8 8
Device Embedded In Tissue or Plaque 8 8
Hypervolemia 7 7
Constipation 7 7
Adhesion(s) 7 7
Erythema 7 7
Thrombosis 7 7
Hernia 6 6
Discomfort 6 6
No Known Impact Or Consequence To Patient 5 5
Nausea 5 5
Hematoma 5 5
Dyspnea 5 5
Chest Pain 4 4
Cardiac Arrest 4 4
Inflammation 4 4
Obstruction/Occlusion 4 4
Injury 4 4
Abdominal Distention 3 3
Radiation Exposure, Unintended 3 3
Cough 3 3
Chills 3 3
Swelling 3 3
Stroke/CVA 3 3
Bradycardia 3 3
Abscess 3 3
Pulmonary Embolism 3 3
Purulent Discharge 3 3
Hemothorax 3 3
Hypersensitivity/Allergic reaction 3 3
Low Blood Pressure/ Hypotension 2 2
Diarrhea 2 2
Endocarditis 2 2
Air Embolism 2 2
Wound Dehiscence 2 2
Cyst(s) 2 2
Muscle Weakness 2 2
Myocardial Infarction 2 2
Renal Failure 2 2
Scar Tissue 2 2
Urinary Retention 2 2
Physical Entrapment 2 2
Respiratory Insufficiency 2 2
Unspecified Respiratory Problem 2 2
Angioedema 2 2
Thrombocytopenia 2 2
No Patient Involvement 2 2
Abdominal Cramps 2 2
Confusion/ Disorientation 2 2
Perforation of Vessels 2 2
Fluid Discharge 2 2
Bowel Perforation 1 1
Full thickness (Third Degree) Burn 1 1
Fibrosis 1 1
Blood Loss 1 1
Thromboembolism 1 1
Malaise 1 1
Impaired Healing 1 1
Loss of consciousness 1 1
Asystole 1 1
Convulsion/Seizure 1 1
Multiple Organ Failure 1 1
Drug Resistant Bacterial Infection 1 1
Implant Pain 1 1
Alteration in Body Temperature 1 1
Reaction to Medicinal Component of Device 1 1
Pancreatitis 1 1
Renal Impairment 1 1
Kidney Infection 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Viral Infection 1 1
Urinary Tract Infection 1 1
Electrolyte Imbalance 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Cardiac Perforation 1 1
Sleep Dysfunction 1 1

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