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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, irrigation
Product CodeGBX
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2018 277 277
2019 196 196
2020 198 198
2021 383 383
2022 478 478

Device Problems MDRs with this Device Problem Events in those MDRs
Break 320 320
Fracture 233 233
Fluid/Blood Leak 176 176
Adverse Event Without Identified Device or Use Problem 106 106
Leak/Splash 66 66
Crack 61 61
Material Separation 57 57
Infusion or Flow Problem 52 52
Device Contamination with Chemical or Other Material 51 51
Material Fragmentation 49 49
Dull, Blunt 46 46
Defective Component 45 45
Suction Problem 38 38
Appropriate Term/Code Not Available 37 37
Detachment of Device or Device Component 31 31
Disconnection 30 30
Device Contaminated During Manufacture or Shipping 25 25
No Apparent Adverse Event 25 25
Contamination /Decontamination Problem 22 22
Entrapment of Device 21 21
Unraveled Material 21 21
Difficult to Remove 20 20
Material Split, Cut or Torn 16 16
Material Deformation 12 12
Use of Device Problem 11 11
Obstruction of Flow 10 10
Misassembled 10 10
Material Integrity Problem 10 10
Physical Resistance/Sticking 10 10
Component Misassembled 10 10
Restricted Flow rate 9 9
Improper or Incorrect Procedure or Method 9 9
Material Puncture/Hole 9 9
Particulates 8 8
Fitting Problem 8 8
Deformation Due to Compressive Stress 8 8
Failure to Advance 7 7
Migration or Expulsion of Device 7 7
Material Frayed 6 6
Nonstandard Device 6 6
Loose or Intermittent Connection 6 6
Mechanical Problem 6 6
Partial Blockage 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Twisted/Bent 6 6
Suction Failure 6 6
Defective Device 5 5
Device Operates Differently Than Expected 5 5
Kinked 5 5
Failure to Read Input Signal 5 5
Material Rupture 4 4
Device Damaged Prior to Use 4 4
Complete Blockage 4 4
Decrease in Suction 4 4
Detachment Of Device Component 4 4
Contamination 4 4
Flaked 4 4
Device Dislodged or Dislocated 4 4
Material Protrusion/Extrusion 4 4
Insufficient Information 4 4
No Flow 3 3
Packaging Problem 3 3
Material Too Soft/Flexible 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Difficult to Advance 3 3
Malposition of Device 3 3
Device Markings/Labelling Problem 3 3
Aspiration Issue 3 3
Collapse 3 3
Difficult to Insert 3 3
Disassembly 3 3
Component Missing 3 3
Sticking 3 3
Device Slipped 2 2
Material Perforation 2 2
Failure to Infuse 2 2
Unsealed Device Packaging 2 2
Material Too Rigid or Stiff 2 2
Peeled/Delaminated 2 2
Off-Label Use 2 2
Product Quality Problem 2 2
Corroded 2 2
Loss of or Failure to Bond 2 2
Difficult to Fold, Unfold or Collapse 2 2
Delivered as Unsterile Product 2 2
Patient-Device Incompatibility 2 2
Physical Resistance 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Torn Material 2 2
Device Fell 2 2
Unclear Information 2 2
Missing Information 1 1
Air/Gas in Device 1 1
Incomplete or Inadequate Connection 1 1
Separation Problem 1 1
Illegible Information 1 1
Physical Property Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 683 683
No Consequences Or Impact To Patient 310 310
No Known Impact Or Consequence To Patient 184 184
Foreign Body In Patient 143 143
No Patient Involvement 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 47
Not Applicable 44 44
No Code Available 41 41
Insufficient Information 30 30
Unspecified Infection 25 25
Device Embedded In Tissue or Plaque 23 23
Pneumothorax 19 19
Fistula 18 18
Failure to Anastomose 17 17
Hematoma 16 16
Pain 16 16
Hemorrhage/Bleeding 15 15
Seroma 15 15
No Information 14 14
Patient Problem/Medical Problem 11 11
Injury 9 9
Post Operative Wound Infection 9 9
Wound Dehiscence 9 9
Endophthalmitis 9 9
Inflammation 8 8
Pleural Effusion 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Bacterial Infection 7 7
Abscess 6 6
Pneumonia 6 6
Failure of Implant 6 6
Obstruction/Occlusion 6 6
Capsular Bag Tear 6 6
Blood Loss 6 6
Sepsis 5 5
Death 5 5
Necrosis 5 5
Erythema 4 4
Uveitis 4 4
Impaired Healing 3 3
Cardiac Tamponade 3 3
Conjunctivitis 3 3
Atrial Fibrillation 3 3
Low Blood Pressure/ Hypotension 3 3
Hypoxia 3 3
Fever 2 2
Hemothorax 2 2
Hypopyon 2 2
Nerve Damage 2 2
Corneal Edema 2 2
Cellulitis 2 2
Chest Pain 2 2
Dehydration 2 2
Dyspnea 2 2
Tachycardia 2 2
Vomiting 2 2
Discomfort 2 2
Blurred Vision 2 2
Paresis 2 2
Fluid Discharge 2 2
Pericardial Effusion 2 2
Thrombosis/Thrombus 1 1
Respiratory Insufficiency 1 1
Eye Pain 1 1
Intraocular Pressure Decreased 1 1
Pseudoaneurysm 1 1
Tissue Breakdown 1 1
Angioedema 1 1
Swelling/ Edema 1 1
Rash 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Vitreous Loss 1 1
Septic Shock 1 1
Skin Irritation 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Hernia 1 1
Wheal(s) 1 1
Infection, Pyrogenic 1 1
Ulcer 1 1
Pressure Sores 1 1
Fasciitis 1 1
Post Traumatic Wound Infection 1 1
Low Oxygen Saturation 1 1
Cardiac Perforation 1 1
Eye Burn 1 1
Confusion/ Disorientation 1 1
Vascular System (Circulation), Impaired 1 1
Extravasation 1 1
Crushing Injury 1 1
Adhesion(s) 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Abdominal Pain 1 1
Abnormal Blood Gases 1 1
Internal Organ Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jan-18-2023
2 Cardinal Health 200, LLC II Jul-18-2018
3 Centese Inc. II Oct-13-2021
4 Cook Inc. II Mar-24-2020
5 Degania Silicone, Ltd. II Aug-12-2019
6 Degania Silicone, Ltd. III Feb-20-2018
7 Maquet Cardiovascular, LLC II Jan-19-2023
8 TELEFLEX MEDICAL INC II Mar-24-2021
9 TELEFLEX MEDICAL INC II Aug-28-2020
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