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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 477 477
2023 494 494

Device Problems MDRs with this Device Problem Events in those MDRs
Break 420 420
Fracture 419 419
Fluid/Blood Leak 193 193
Defective Component 131 131
Material Separation 125 125
Adverse Event Without Identified Device or Use Problem 117 117
Leak/Splash 82 82
Infusion or Flow Problem 64 64
Material Fragmentation 62 62
Crack 61 61
Device Contamination with Chemical or Other Material 58 58
Dull, Blunt 50 50
Suction Problem 40 40
Appropriate Term/Code Not Available 37 37
Detachment of Device or Device Component 35 35
Disconnection 31 31
Device Contaminated During Manufacture or Shipping 28 28
Unraveled Material 27 27
Difficult to Remove 25 25
No Apparent Adverse Event 25 25
Material Integrity Problem 23 23
Contamination /Decontamination Problem 22 22
Entrapment of Device 22 22
Obstruction of Flow 15 15
Material Split, Cut or Torn 15 15
Material Deformation 12 12
Use of Device Problem 12 12
Restricted Flow rate 11 11
Component Misassembled 11 11
Physical Resistance/Sticking 10 10
Deformation Due to Compressive Stress 10 10
Misassembled 10 10
Fitting Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Particulates 9 9
Material Puncture/Hole 9 9
Material Twisted/Bent 8 8
Failure to Advance 8 8
Suction Failure 8 8
Migration or Expulsion of Device 7 7
Difficult to Insert 7 7
Nonstandard Device 6 6
Material Frayed 6 6
Partial Blockage 6 6
Loose or Intermittent Connection 6 6
Mechanical Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Defective Device 5 5
Material Protrusion/Extrusion 5 5
Device Operates Differently Than Expected 5 5
Failure to Read Input Signal 5 5
Component Missing 5 5
Device Damaged Prior to Use 5 5
Contamination 5 5
Kinked 5 5
Difficult to Fold, Unfold or Collapse 4 4
Flaked 4 4
Detachment Of Device Component 4 4
Decrease in Suction 4 4
Complete Blockage 4 4
Material Rupture 4 4
Device Dislodged or Dislocated 4 4
Insufficient Information 4 4
Packaging Problem 3 3
Material Too Soft/Flexible 3 3
Air/Gas in Device 3 3
Difficult to Advance 3 3
Device Markings/Labelling Problem 3 3
No Flow 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Malposition of Device 3 3
Aspiration Issue 3 3
Unsealed Device Packaging 3 3
Sticking 3 3
Disassembly 3 3
Collapse 3 3
Corroded 2 2
Difficult or Delayed Positioning 2 2
Loss of or Failure to Bond 2 2
Delivered as Unsterile Product 2 2
Device Slipped 2 2
Insufficient Flow or Under Infusion 2 2
Failure to Infuse 2 2
Material Perforation 2 2
Product Quality Problem 2 2
Peeled/Delaminated 2 2
Off-Label Use 2 2
Connection Problem 2 2
Patient-Device Incompatibility 2 2
Physical Resistance 2 2
Gas/Air Leak 2 2
Device Fell 2 2
Separation Problem 2 2
Illegible Information 2 2
Unclear Information 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1118 1118
No Consequences Or Impact To Patient 310 310
No Known Impact Or Consequence To Patient 184 184
Foreign Body In Patient 173 173
No Patient Involvement 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Insufficient Information 44 44
Not Applicable 44 44
No Code Available 41 41
Unspecified Infection 30 30
Device Embedded In Tissue or Plaque 23 23
Hematoma 19 19
Pneumothorax 19 19
Pain 18 18
Fistula 18 18
Hemorrhage/Bleeding 17 17
Failure to Anastomose 17 17
Seroma 16 16
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
Bacterial Infection 8 8
Pleural Effusion 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Abscess 7 7
Pneumonia 6 6
Failure of Implant 6 6
Necrosis 6 6
Capsular Bag Tear 6 6
Blood Loss 6 6
Obstruction/Occlusion 6 6
Sepsis 5 5
Death 5 5
Atrial Fibrillation 4 4
Fever 4 4
Erythema 4 4
Hypoxia 4 4
Uveitis 4 4
Cardiac Tamponade 4 4
Internal Organ Perforation 3 3
Conjunctivitis 3 3
Low Blood Pressure/ Hypotension 3 3
Abdominal Pain 3 3
Impaired Healing 3 3
Vomiting 2 2
Chills 2 2
Scar Tissue 2 2
Discomfort 2 2
Low Oxygen Saturation 2 2
Fluid Discharge 2 2
Pericardial Effusion 2 2
Dehydration 2 2
Dyspnea 2 2
Cellulitis 2 2
Chest Pain 2 2
Corneal Edema 2 2
Hemothorax 2 2
Hypopyon 2 2
Paresis 2 2
Nerve Damage 2 2
Blurred Vision 2 2
Tachycardia 2 2
Tissue Damage 1 1
Urinary Tract Infection 1 1
Shock 1 1
Skin Irritation 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Vitreous Loss 1 1
Hernia 1 1
Wheal(s) 1 1
Infection, Pyrogenic 1 1
Ulcer 1 1
Pressure Sores 1 1
Anxiety 1 1
Paralysis 1 1
Septic Shock 1 1
Rash 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Crushing Injury 1 1
Extravasation 1 1
Ischemia 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Nausea 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Endocarditis 1 1
Abnormal Blood Gases 1 1
Adhesion(s) 1 1
Rheumatoid Arthritis 1 1
Asthma 1 1
Thrombosis/Thrombus 1 1
Respiratory Insufficiency 1 1
Eye Pain 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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