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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 704 704

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 799 799
Break 452 452
Fluid/Blood Leak 225 225
Material Separation 222 222
Defective Component 207 207
Adverse Event Without Identified Device or Use Problem 124 124
Leak/Splash 105 105
Material Fragmentation 80 80
Infusion or Flow Problem 74 74
Device Contaminated During Manufacture or Shipping 73 73
Dull, Blunt 54 54
Device Contamination with Chemical or Other Material 48 48
Disconnection 37 37
Detachment of Device or Device Component 37 37
Material Integrity Problem 37 37
Suction Problem 33 33
Unraveled Material 33 33
Difficult to Remove 28 28
Crack 26 26
No Apparent Adverse Event 25 25
Obstruction of Flow 25 25
Contamination /Decontamination Problem 21 21
Deformation Due to Compressive Stress 19 19
Material Split, Cut or Torn 18 18
Entrapment of Device 16 16
Suction Failure 16 16
Material Twisted/Bent 14 14
Component Misassembled 13 13
Material Puncture/Hole 13 13
Restricted Flow rate 12 12
Material Deformation 11 11
Use of Device Problem 10 10
Device Damaged Prior to Use 10 10
Physical Resistance/Sticking 10 10
Improper or Incorrect Procedure or Method 9 9
Appropriate Term/Code Not Available 9 9
Particulates 9 9
Fitting Problem 7 7
Migration or Expulsion of Device 7 7
Difficult to Insert 7 7
Failure to Advance 6 6
Tear, Rip or Hole in Device Packaging 6 6
Loose or Intermittent Connection 5 5
Device Dislodged or Dislocated 5 5
Component Missing 5 5
Material Frayed 4 4
Loss of or Failure to Bond 4 4
Insufficient Information 4 4
Difficult to Fold, Unfold or Collapse 4 4
Difficult to Flush 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1847 1847
No Consequences Or Impact To Patient 213 213
Foreign Body In Patient 196 196
No Known Impact Or Consequence To Patient 79 79
Insufficient Information 71 71
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 58 58
No Patient Involvement 44 44
Unspecified Infection 38 38
No Code Available 25 25
Hematoma 22 22
Hemorrhage/Bleeding 20 20
Device Embedded In Tissue or Plaque 19 19
Pneumothorax 19 19
Failure to Anastomose 18 18
Not Applicable 18 18
Seroma 17 17
Pain 16 16
Fistula 14 14
Post Operative Wound Infection 12 12
Endophthalmitis 9 9
Patient Problem/Medical Problem 9 9
Wound Dehiscence 9 9
Bacterial Infection 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Failure of Implant 8 8
Necrosis 7 7
Inflammation 7 7
Abscess 7 7
Pleural Effusion 6 6
Obstruction/Occlusion 6 6
Sepsis 5 5
Cardiac Tamponade 5 5
Capsular Bag Tear 5 5
Injury 5 5
Pneumonia 5 5
Low Blood Pressure/ Hypotension 4 4
No Information 4 4
Atrial Fibrillation 4 4
Impaired Healing 4 4
Hypoxia 4 4
Unspecified Tissue Injury 4 4
Uveitis 4 4
Fever 4 4
Abdominal Pain 3 3
Erythema 3 3
Conjunctivitis 3 3
Low Oxygen Saturation 3 3
Cellulitis 3 3
Blood Loss 3 3
Urinary Tract Infection 2 2

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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