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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, irrigation
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBX
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2020 198 198
2021 383 383
2022 477 477
2023 629 629
2024 945 945
2025 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 896 896
Break 422 422
Fluid/Blood Leak 266 266
Material Separation 262 262
Defective Component 245 245
Adverse Event Without Identified Device or Use Problem 134 134
Leak/Splash 112 112
Device Contaminated During Manufacture or Shipping 81 81
Infusion or Flow Problem 76 76
Material Fragmentation 75 75
Dull, Blunt 59 59
Device Contamination with Chemical or Other Material 45 45
Material Integrity Problem 40 40
Disconnection 38 38
Unraveled Material 29 29
Detachment of Device or Device Component 26 26
No Apparent Adverse Event 25 25
Deformation Due to Compressive Stress 24 24
Obstruction of Flow 22 22
Suction Failure 21 21
Suction Problem 21 21
Difficult to Remove 20 20
Material Split, Cut or Torn 17 17
Contamination /Decontamination Problem 16 16
Material Twisted/Bent 15 15
Component Misassembled 15 15
Restricted Flow rate 14 14
Entrapment of Device 13 13
Crack 12 12
Fitting Problem 10 10
Difficult to Insert 10 10
Use of Device Problem 10 10
Material Puncture/Hole 10 10
Improper or Incorrect Procedure or Method 8 8
Device Damaged Prior to Use 8 8
Appropriate Term/Code Not Available 8 8
Physical Resistance/Sticking 7 7
Material Deformation 7 7
Wrong Label 7 7
Material Too Soft/Flexible 6 6
Failure to Advance 6 6
Malposition of Device 5 5
Migration or Expulsion of Device 5 5
Particulates 5 5
Partial Blockage 5 5
Decrease in Suction 5 5
Tear, Rip or Hole in Device Packaging 5 5
Component Missing 5 5
Difficult to Flush 5 5
Incorrect Measurement 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2103 2103
Foreign Body In Patient 181 181
No Consequences Or Impact To Patient 120 120
Insufficient Information 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
Unspecified Infection 40 40
No Known Impact Or Consequence To Patient 27 27
No Patient Involvement 23 23
Pain 23 23
Hemorrhage/Bleeding 22 22
Hematoma 21 21
Endophthalmitis 21 21
Pneumothorax 19 19
Seroma 19 19
Failure to Anastomose 18 18
Fistula 14 14
No Code Available 13 13
Not Applicable 12 12
Post Operative Wound Infection 11 11
Wound Dehiscence 10 10
Extravasation 9 9
Inflammation 8 8
Pleural Effusion 8 8
Bacterial Infection 8 8
Failure of Implant 8 8
Necrosis 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Device Embedded In Tissue or Plaque 7 7
Obstruction/Occlusion 6 6
Abscess 6 6
Pneumonia 6 6
Cardiac Tamponade 6 6
Erythema 5 5
Thrombosis/Thrombus 4 4
Impaired Healing 4 4
Hypoxia 4 4
Fever 4 4
Low Blood Pressure/ Hypotension 4 4
Atrial Fibrillation 4 4
Unspecified Tissue Injury 4 4
Sepsis 4 4
Uveitis 4 4
Capsular Bag Tear 4 4
Infiltration into Tissue 3 3
Conjunctivitis 3 3
Numbness 3 3
Cellulitis 3 3
Low Oxygen Saturation 3 3
No Information 3 3
Abdominal Pain 3 3

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 Maquet Cardiovascular, LLC II Jan-19-2023
6 TELEFLEX MEDICAL INC II Mar-24-2021
7 TELEFLEX MEDICAL INC II Aug-28-2020
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