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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter and tip, suction
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeJOL
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2020 187 187
2021 283 283
2022 221 221
2023 197 197
2024 277 277
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 518 518
Leak/Splash 145 145
Suction Problem 87 87
Break 53 53
Material Separation 50 50
Material Integrity Problem 44 44
Adverse Event Without Identified Device or Use Problem 42 42
Unraveled Material 35 35
Device Contaminated During Manufacture or Shipping 31 31
Detachment of Device or Device Component 27 27
Activation Problem 19 19
Use of Device Problem 16 16
Material Deformation 14 14
Difficult to Remove 12 12
No Flow 10 10
Suction Failure 8 8
Contamination /Decontamination Problem 8 8
Fluid/Blood Leak 8 8
Material Twisted/Bent 7 7
Entrapment of Device 7 7
Insufficient Information 7 7
Material Frayed 6 6
Gas/Air Leak 5 5
Material Puncture/Hole 5 5
Malposition of Device 5 5
Improper or Incorrect Procedure or Method 4 4
Component Missing 4 4
Patient Device Interaction Problem 4 4
Delivered as Unsterile Product 4 4
Deformation Due to Compressive Stress 4 4
Material Split, Cut or Torn 4 4
Crack 4 4
Fitting Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Partial Blockage 3 3
No Apparent Adverse Event 3 3
Physical Resistance/Sticking 3 3
Connection Problem 3 3
Device Damaged Prior to Use 3 3
Fracture 2 2
Output Problem 2 2
Defective Component 2 2
Sharp Edges 2 2
Backflow 2 2
Difficult to Advance 2 2
Decrease in Suction 2 2
Material Fragmentation 1 1
Difficult to Open or Remove Packaging Material 1 1
Device-Device Incompatibility 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 888 888
No Consequences Or Impact To Patient 108 108
Insufficient Information 58 58
Pneumothorax 32 32
Foreign Body In Patient 31 31
No Patient Involvement 16 16
No Code Available 11 11
Unspecified Infection 9 9
Hemorrhage/Bleeding 8 8
Pain 6 6
Failure to Anastomose 6 6
Seroma 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Internal Organ Perforation 6 6
Air Embolism 5 5
Swelling 5 5
Not Applicable 5 5
Inflammation 5 5
Reaction 4 4
Hematoma 4 4
Cardiac Tamponade 4 4
Swelling/ Edema 3 3
Pleural Effusion 3 3
Low Oxygen Saturation 3 3
No Known Impact Or Consequence To Patient 3 3
Necrosis 3 3
Laceration(s) 3 3
Pulmonary Emphysema 3 3
Cardiac Perforation 3 3
Unspecified Tissue Injury 2 2
Airway Obstruction 2 2
Loss of consciousness 2 2
Pneumonia 2 2
Bradycardia 2 2
Impaired Healing 2 2
Aspiration/Inhalation 2 2
Device Embedded In Tissue or Plaque 2 2
Abdominal Pain 2 2
Needle Stick/Puncture 2 2
No Information 2 2
Respiratory Distress 2 2
Fistula 2 2
Skin Tears 1 1
Perforation of Vessels 1 1
Increased Respiratory Rate 1 1
Adult Respiratory Distress Syndrome 1 1
Respiratory Failure 1 1
Vascular Dissection 1 1
Pseudoaneurysm 1 1
Chest Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
4 Merit Medical Systems, Inc. II Aug-12-2024
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