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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
Product CodeJOL
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2019 442 442
2020 187 187
2021 283 283
2022 221 221
2023 197 197
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 404 404
Device Contamination with Chemical or Other Material 284 284
Suction Problem 153 153
Leak/Splash 115 115
Material Separation 54 54
Break 50 50
Adverse Event Without Identified Device or Use Problem 34 34
Material Integrity Problem 31 31
Device Contaminated During Manufacture or Shipping 27 27
Unraveled Material 27 27
Detachment of Device or Device Component 25 25
Fluid/Blood Leak 22 22
Activation Problem 14 14
Use of Device Problem 12 12
Difficult to Remove 11 11
Suction Failure 10 10
Contamination /Decontamination Problem 10 10
No Flow 10 10
Entrapment of Device 8 8
Material Frayed 7 7
Delivered as Unsterile Product 6 6
Material Deformation 6 6
Insufficient Information 5 5
Material Split, Cut or Torn 5 5
Crack 5 5
Decrease in Suction 5 5
Material Puncture/Hole 5 5
Improper or Incorrect Procedure or Method 4 4
Fitting Problem 4 4
Physical Resistance/Sticking 4 4
Gas/Air Leak 4 4
Component Missing 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Twisted/Bent 3 3
No Apparent Adverse Event 3 3
Separation Problem 3 3
Device Damaged Prior to Use 3 3
Disconnection 3 3
Partial Blockage 3 3
Backflow 2 2
Complete Blockage 2 2
Fracture 2 2
Inaccurate Information 2 2
Sharp Edges 2 2
Output Problem 2 2
Device Markings/Labelling Problem 2 2
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1
Mechanical Jam 1 1
Packaging Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Noise, Audible 1 1
Air/Gas in Device 1 1
Material Fragmentation 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Defective Component 1 1
Material Perforation 1 1
Failure to Disconnect 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 660 660
No Patient Involvement 314 314
No Consequences Or Impact To Patient 222 222
Insufficient Information 33 33
Pneumothorax 29 29
No Code Available 16 16
Foreign Body In Patient 16 16
No Known Impact Or Consequence To Patient 14 14
Hemorrhage/Bleeding 8 8
Pain 7 7
Unspecified Infection 6 6
Seroma 6 6
Swelling 6 6
Not Applicable 6 6
Inflammation 5 5
Failure to Anastomose 5 5
Bradycardia 5 5
Cardiac Tamponade 4 4
Reaction 4 4
Internal Organ Perforation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Device Embedded In Tissue or Plaque 3 3
Low Oxygen Saturation 3 3
No Information 3 3
Necrosis 3 3
Pleural Effusion 3 3
Air Embolism 3 3
Fistula 3 3
Hematoma 3 3
Death 3 3
Pneumonia 2 2
Respiratory Distress 2 2
Chest Pain 2 2
Laceration(s) 2 2
Cardiac Perforation 2 2
Impaired Healing 2 2
Loss of consciousness 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 1 1
Unspecified Respiratory Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Pseudoaneurysm 1 1
Partial thickness (Second Degree) Burn 1 1
Vascular Dissection 1 1
Distress 1 1
Injury 1 1
Tachycardia 1 1
Shock 1 1
Dyspnea 1 1
Ecchymosis 1 1
Extravasation 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Airway Obstruction 1 1
Apnea 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Abdominal Pain 1 1
Adult Respiratory Distress Syndrome 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 ConvaTec, Inc II Mar-21-2019
3 Cook Inc. II Nov-21-2019
4 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
5 Santanello Surgical LLC II Aug-09-2019
6 Teleflex Medical II Feb-16-2019
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