Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Break 180 180
Adverse Event Without Identified Device or Use Problem 113 113
Product Quality Problem 69 69
Malposition of Device 62 62
Insufficient Information 58 58
Appropriate Term/Code Not Available 58 58
Obstruction of Flow 57 57
Material Puncture/Hole 41 41
Migration or Expulsion of Device 40 40
Connection Problem 40 40
Infusion or Flow Problem 40 40
Improper or Incorrect Procedure or Method 34 34
Fluid/Blood Leak 31 31
Migration 31 31
Insufficient Flow or Under Infusion 25 25
Positioning Problem 25 25
Detachment of Device or Device Component 22 22
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
Contamination 9 9
Material Split, Cut or Torn 9 9
Fracture 8 8
Material Twisted/Bent 8 8
Crack 7 7
No Flow 6 6
Material Integrity Problem 6 6
Output 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
Difficult to Remove 4 4
Material Perforation 4 4
Use of Device Problem 4 4
Partial Blockage 4 4
Entrapment of Device 4 4
Component Missing 4 4
Failure to Clean Adequately 4 4
Patient Device Interaction Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Unintended Movement 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 Dislodged or Dislocated 2 2
Patient-Device Incompatibility 2 2
Device Displays Incorrect Message 2 2
Physical Resistance/Sticking 2 2
Device Fell 2 2
Separation Problem 1 1
Data Problem 1 1
Noise, Audible 1 1
Failure to Advance 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult to Advance 1 1
Filtration Problem 1 1
Scratched Material 1 1
Power Problem 1 1
Manufacturing, Packaging or Shipping 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
Misconnection 1 1
Moisture Damage 1 1
Material Rupture 1 1
Short Fill 1 1
Device Slipped 1 1
Unraveled Material 1 1
Volume Accuracy Problem 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 250 250
No Clinical Signs, Symptoms or Conditions 201 201
Peritonitis 193 193
Unspecified Infection 106 106
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
Hemorrhage/Bleeding 12 12
Thrombosis/Thrombus 11 11
Foreign Body In Patient 11 11
Swelling/ Edema 11 11
Sepsis 10 10
Vomiting 8 8
Death 8 8
No Code Available 8 8
Constipation 7 7
Device Embedded In Tissue or Plaque 7 7
Hypervolemia 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
-
-