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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, subclavian
Regulation Description Blood access device and accessories.
Product CodeLFJ
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2019 45 45
2020 43 43
2021 37 37
2022 34 34
2023 44 44
2024 48 48
2025 28 28
2026 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Unraveled Material 44 44
Material Twisted/Bent 44 44
Material Deformation 39 39
Deformation Due to Compressive Stress 30 30
Break 27 27
Physical Resistance/Sticking 20 20
Fluid/Blood Leak 18 18
Material Frayed 15 15
Material Separation 12 12
Difficult to Remove 9 9
Difficult to Insert 9 9
Fracture 8 8
Material Puncture/Hole 8 8
Component Incompatible 7 7
Obstruction of Flow 7 7
Crack 6 6
Gas/Air Leak 5 5
Material Integrity Problem 4 4
Entrapment of Device 4 4
Product Quality Problem 4 4
Leak/Splash 4 4
Defective Component 4 4
Failure to Infuse 4 4
Suction Problem 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Complete Blockage 2 2
Insufficient Information 2 2
Material Too Soft/Flexible 2 2
Material Split, Cut or Torn 2 2
Suction Failure 1 1
Migration 1 1
Component Misassembled 1 1
Improper Flow or Infusion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Advance 1 1
Naturally Worn 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Pumping Problem 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
Material Discolored 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Material Fragmentation 1 1
Material Invagination 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Stretched 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 189 189
No Consequences Or Impact To Patient 57 57
No Known Impact Or Consequence To Patient 18 18
Insufficient Information 12 12
Unspecified Infection 3 3
No Patient Involvement 3 3
Hemorrhage/Bleeding 3 3
Intraoperative Pain 2 2
Hematoma 2 2
Anemia 2 2
Chest Pain 2 2
Vessel Or Plaque, Device Embedded In 1 1
Stacking Breaths 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Death 1 1
Nausea 1 1
Sepsis 1 1
Diaphoresis 1 1
No Code Available 1 1
Easy Bruising 1 1
Cardiac Arrest 1 1
Fever 1 1
Foreign Body In Patient 1 1
Pain 1 1
Myocardial Infarction 1 1
Bacterial Infection 1 1
Loss of consciousness 1 1
Respiratory Insufficiency 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Components, Inc dba MedComp II Aug-08-2019
2 Medical Components, Inc dba MedComp II Apr-16-2019
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