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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
2017 176 176
2018 277 277
2019 196 196
2020 198 198
2021 383 383
2022 277 277

Device Problems MDRs with this Device Problem Events in those MDRs
Break 331 331
Fracture 217 217
Adverse Event Without Identified Device or Use Problem 104 104
Fluid Leak 94 94
Crack 85 85
Leak/Splash 64 64
Material Separation 63 63
Device Contamination with Chemical or Other Material 51 51
Material Fragmentation 46 46
Infusion or Flow Problem 46 46
Dull, Blunt 46 46
Suction Problem 40 40
Appropriate Term/Code Not Available 39 39
Disconnection 31 31
Detachment of Device or Device Component 30 30
No Apparent Adverse Event 25 25
Defective Component 25 25
Device Contaminated During Manufacture or Shipping 24 24
Unraveled Material 24 24
Difficult to Remove 23 23
Contamination /Decontamination Problem 22 22
Entrapment of Device 22 22
Material Split, Cut or Torn 16 16
Detachment Of Device Component 13 13
Material Deformation 12 12
Physical Resistance/Sticking 10 10
Obstruction of Flow 10 10
Kinked 10 10
Misassembled 10 10
Component Misassembled 10 10
Device Markings/Labelling Problem 9 9
Restricted Flow rate 9 9
Use of Device Problem 9 9
Material Puncture/Hole 9 9
Failure to Advance 9 9
Improper or Incorrect Procedure or Method 9 9
Device Operates Differently Than Expected 9 9
Fitting Problem 8 8
Material Integrity Problem 8 8
Particulates 8 8
Material Frayed 8 8
Device Damaged Prior to Use 7 7
Insufficient Information 7 7
Migration or Expulsion of Device 7 7
Material Twisted/Bent 7 7
Inadequacy of Device Shape and/or Size 6 6
Sticking 6 6
Partial Blockage 6 6
Suction Failure 6 6
No Flow 6 6
Packaging Problem 6 6
Mechanical Problem 6 6
Nonstandard Device 6 6
Deformation Due to Compressive Stress 6 6
Defective Device 6 6
Component Missing 5 5
Loose or Intermittent Connection 5 5
Failure to Read Input Signal 5 5
Tear, Rip or Hole in Device Packaging 5 5
Aspiration Issue 5 5
Physical Resistance 5 5
Material Protrusion/Extrusion 4 4
Complete Blockage 4 4
Incorrect Device Or Component Shipped 4 4
Contamination 4 4
Delivered as Unsterile Product 4 4
Occlusion Within Device 4 4
Material Rupture 4 4
Flaked 4 4
Decrease in Suction 4 4
Split 4 4
Incorrect Measurement 4 4
Disassembly 4 4
Collapse 4 4
Device Dislodged or Dislocated 4 4
Torn Material 3 3
Physical Property Issue 3 3
Material Too Soft/Flexible 3 3
Difficult to Insert 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Malposition of Device 3 3
Contamination of Device Ingredient or Reagent 3 3
Bent 3 3
Folded 3 3
Patient-Device Incompatibility 2 2
Patient Device Interaction Problem 2 2
Off-Label Use 2 2
Unclear Information 2 2
Air Leak 2 2
Device Operational Issue 2 2
Device Packaging Compromised 2 2
Material Too Rigid or Stiff 2 2
Separation Failure 2 2
Device Fell 2 2
Corroded 2 2
Difficult to Fold, Unfold or Collapse 2 2
Device Inoperable 2 2
Peeled/Delaminated 2 2
Product Quality Problem 2 2
Failure to Infuse 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 507 507
No Consequences Or Impact To Patient 326 326
No Known Impact Or Consequence To Patient 264 264
Foreign Body In Patient 146 146
No Patient Involvement 86 86
No Code Available 56 56
Not Applicable 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Device Embedded In Tissue or Plaque 32 32
Unspecified Infection 29 29
Insufficient Information 27 27
No Information 25 25
Pain 21 21
Pneumothorax 19 19
Fistula 18 18
Hematoma 18 18
Failure to Anastomose 17 17
Seroma 15 15
Hemorrhage/Bleeding 14 14
Injury 11 11
Patient Problem/Medical Problem 11 11
Post Operative Wound Infection 9 9
Wound Dehiscence 9 9
Bacterial Infection 8 8
Death 8 8
Blood Loss 8 8
Pleural Effusion 8 8
Abscess 7 7
Inflammation 7 7
Pneumonia 6 6
Obstruction/Occlusion 6 6
Capsular Bag Tear 6 6
Toxic Anterior Segment Syndrome (TASS) 5 5
Sepsis 5 5
Necrosis 5 5
Endophthalmitis 5 5
Erythema 4 4
Fever 4 4
Low Blood Pressure/ Hypotension 4 4
Failure of Implant 4 4
Cardiac Tamponade 4 4
Discomfort 3 3
Impaired Healing 3 3
Hypoxia 3 3
Atrial Fibrillation 3 3
Pericardial Effusion 3 3
Fluid Discharge 2 2
Bowel Perforation 2 2
Dehydration 2 2
Dyspnea 2 2
Cellulitis 2 2
Chest Pain 2 2
Adhesion(s) 2 2
Abdominal Pain 2 2
Hemothorax 2 2
Nerve Damage 2 2
Paralysis 2 2
Paresis 2 2
Vomiting 2 2
Tachycardia 2 2
Tissue Damage 2 2
Urinary Tract Infection 2 2
Vitreous Loss 1 1
Skin Irritation 1 1
Discharge 1 1
Septic Shock 1 1
Rash 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Fasciitis 1 1
Wheal(s) 1 1
Infection, Pyrogenic 1 1
Ulcer 1 1
Pressure Sores 1 1
Pseudoaneurysm 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
Internal Organ Perforation 1 1
Ischemia 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Nausea 1 1
Incontinence 1 1
Abnormal Blood Gases 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Crushing Injury 1 1
Extravasation 1 1
Tissue Breakdown 1 1
Nervous System Injury 1 1
Thrombosis/Thrombus 1 1
Respiratory Insufficiency 1 1
Intraocular Pressure Decreased 1 1
Angioedema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jul-18-2018
2 Cardinal Health 200, LLC II May-23-2017
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 Degania Silicone, Ltd. II Feb-22-2017
8 TELEFLEX MEDICAL INC II Mar-24-2021
9 TELEFLEX MEDICAL INC II Aug-28-2020
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