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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
2019 196 196
2020 198 198
2021 383 383
2022 477 477
2023 629 629
2024 266 266

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 585 585
Break 406 406
Fluid/Blood Leak 200 200
Material Separation 167 167
Defective Component 162 162
Adverse Event Without Identified Device or Use Problem 109 109
Leak/Splash 95 95
Material Fragmentation 77 77
Infusion or Flow Problem 68 68
Dull, Blunt 53 53
Device Contamination with Chemical or Other Material 47 47
Detachment of Device or Device Component 36 36
Device Contaminated During Manufacture or Shipping 34 34
Disconnection 34 34
Suction Problem 33 33
Unraveled Material 30 30
Difficult to Remove 26 26
Crack 25 25
No Apparent Adverse Event 25 25
Material Integrity Problem 21 21
Contamination /Decontamination Problem 21 21
Obstruction of Flow 19 19
Deformation Due to Compressive Stress 15 15
Entrapment of Device 15 15
Material Split, Cut or Torn 15 15
Suction Failure 14 14
Component Misassembled 12 12
Use of Device Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Particulates 9 9
Material Twisted/Bent 9 9
Material Deformation 8 8
Physical Resistance/Sticking 8 8
Appropriate Term/Code Not Available 8 8
Material Puncture/Hole 8 8
Restricted Flow rate 8 8
Migration or Expulsion of Device 7 7
Fitting Problem 7 7
Tear, Rip or Hole in Device Packaging 6 6
Failure to Advance 6 6
Difficult to Insert 6 6
Loose or Intermittent Connection 5 5
Component Missing 5 5
Material Rupture 4 4
Difficult to Fold, Unfold or Collapse 4 4
Material Frayed 4 4
Decrease in Suction 4 4
Complete Blockage 4 4
Contamination 4 4
Insufficient Information 4 4
Material Protrusion/Extrusion 4 4
Device Dislodged or Dislocated 4 4
Difficult to Advance 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Packaging Problem 3 3
Migration 3 3
Material Too Soft/Flexible 3 3
Air/Gas in Device 3 3
Misassembled 3 3
Nonstandard Device 3 3
Mechanical Problem 3 3
Device Damaged Prior to Use 3 3
Defective Device 3 3
Malposition of Device 3 3
Patient-Device Incompatibility 2 2
Connection Problem 2 2
Failure to Infuse 2 2
Insufficient Flow or Under Infusion 2 2
Unsealed Device Packaging 2 2
Product Quality Problem 2 2
Off-Label Use 2 2
Device Slipped 2 2
Incorrect Measurement 2 2
Difficult to Flush 2 2
Corroded 2 2
Partial Blockage 2 2
Loss of or Failure to Bond 2 2
Difficult or Delayed Positioning 2 2
Flaked 2 2
Separation Problem 2 2
Illegible Information 2 2
Unclear Information 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
No Flow 2 2
Device Markings/Labelling Problem 2 2
Gas/Air Leak 2 2
Human-Device Interface Problem 1 1
Expulsion 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Optical Distortion 1 1
Output Problem 1 1
Unintended Movement 1 1
Positioning Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1448 1448
No Consequences Or Impact To Patient 213 213
Foreign Body In Patient 183 183
No Known Impact Or Consequence To Patient 79 79
Insufficient Information 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
No Patient Involvement 44 44
Unspecified Infection 30 30
No Code Available 25 25
Device Embedded In Tissue or Plaque 19 19
Hematoma 19 19
Not Applicable 18 18
Hemorrhage/Bleeding 17 17
Failure to Anastomose 17 17
Pneumothorax 17 17
Seroma 16 16
Pain 16 16
Fistula 13 13
Post Operative Wound Infection 10 10
Patient Problem/Medical Problem 9 9
Endophthalmitis 9 9
Bacterial Infection 8 8
Failure of Implant 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Wound Dehiscence 7 7
Inflammation 7 7
Abscess 6 6
Pleural Effusion 6 6
Necrosis 6 6
Sepsis 5 5
Injury 5 5
Obstruction/Occlusion 5 5
Capsular Bag Tear 4 4
No Information 4 4
Cardiac Tamponade 4 4
Uveitis 4 4
Pneumonia 4 4
Hypoxia 4 4
Atrial Fibrillation 4 4
Fever 4 4
Erythema 3 3
Conjunctivitis 3 3
Low Blood Pressure/ Hypotension 3 3
Abdominal Pain 3 3
Cellulitis 3 3
Impaired Healing 3 3
Blood Loss 3 3
Unspecified Tissue Injury 3 3
Fluid Discharge 2 2
Low Oxygen Saturation 2 2
Vitreous Loss 2 2
Vomiting 2 2
Chills 2 2
Blurred Vision 2 2
Tachycardia 2 2
Scar Tissue 2 2
Urinary Tract Infection 2 2
Paresis 2 2
Nerve Damage 2 2
Internal Organ Perforation 2 2
Septic Shock 2 2
Chest Pain 2 2
Death 2 2
Dehydration 2 2
Dyspnea 2 2
Hypopyon 2 2
Corneal Edema 2 2
Extravasation 2 2
Crushing Injury 1 1
Hemothorax 1 1
Itching Sensation 1 1
Nausea 1 1
Endocarditis 1 1
Cardiac Arrest 1 1
Abnormal Blood Gases 1 1
Adhesion(s) 1 1
Rheumatoid Arthritis 1 1
Asthma 1 1
Shock 1 1
Skin Irritation 1 1
Rash 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Paralysis 1 1
Tissue Damage 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Respiratory Tract Infection 1 1
Hernia 1 1
Wheal(s) 1 1
Pressure Sores 1 1
Anxiety 1 1
Respiratory Failure 1 1
Cardiac Perforation 1 1
Confusion/ Disorientation 1 1
Vascular System (Circulation), Impaired 1 1
Pseudoaneurysm 1 1
Post Traumatic Wound Infection 1 1
Tissue Breakdown 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II May-01-2024
2 Cardinal Health 200, LLC II Jan-18-2023
3 Centese Inc. II Oct-13-2021
4 Cook Inc. II Mar-24-2020
5 Degania Silicone, Ltd. II Aug-12-2019
6 Maquet Cardiovascular, LLC II Jan-19-2023
7 TELEFLEX MEDICAL INC II Mar-24-2021
8 TELEFLEX MEDICAL INC II Aug-28-2020
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