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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 198 198
2024 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 434 434
Device Contamination with Chemical or Other Material 284 284
Suction Problem 153 153
Leak/Splash 119 119
Material Separation 57 57
Break 52 52
Material Integrity Problem 34 34
Adverse Event Without Identified Device or Use Problem 34 34
Unraveled Material 29 29
Device Contaminated During Manufacture or Shipping 27 27
Detachment of Device or Device Component 27 27
Fluid/Blood Leak 22 22
Activation Problem 15 15
Use of Device Problem 13 13
Difficult to Remove 11 11
Suction Failure 10 10
Contamination /Decontamination Problem 10 10
No Flow 10 10
Material Deformation 9 9
Entrapment of Device 8 8
Material Frayed 7 7
Delivered as Unsterile Product 6 6
Insufficient Information 6 6
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 5 5
Fitting Problem 4 4
Physical Resistance/Sticking 4 4
Component Missing 4 4
Material Twisted/Bent 4 4
Gas/Air Leak 4 4
Manufacturing, Packaging or Shipping Problem 3 3
No Apparent Adverse Event 3 3
Separation Problem 3 3
Device Damaged Prior to Use 3 3
Disconnection 3 3
Fracture 3 3
Partial Blockage 3 3
Backflow 2 2
Complete Blockage 2 2
Defective Component 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 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 708 708
No Patient Involvement 314 314
No Consequences Or Impact To Patient 222 222
Insufficient Information 34 34
Pneumothorax 29 29
Foreign Body In Patient 20 20
No Code Available 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Inflammation 5 5
Failure to Anastomose 5 5
Bradycardia 5 5
Cardiac Tamponade 4 4
Reaction 4 4
Internal Organ Perforation 4 4
Low Oxygen Saturation 3 3
No Information 3 3
Device Embedded In Tissue or Plaque 3 3
Necrosis 3 3
Pleural Effusion 3 3
Air Embolism 3 3
Fistula 3 3
Hematoma 3 3
Death 3 3
Pulmonary Emphysema 3 3
Dyspnea 2 2
Abdominal Pain 2 2
Pneumonia 2 2
Respiratory Distress 2 2
Chest Pain 2 2
Laceration(s) 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 2 2
Cardiac Perforation 2 2
Impaired Healing 2 2
Loss of consciousness 2 2
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Skin Tears 1 1
Pseudoaneurysm 1 1
Partial thickness (Second Degree) Burn 1 1
Vascular Dissection 1 1
Unspecified Respiratory Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Distress 1 1
Injury 1 1
Tachycardia 1 1
Shock 1 1
Adult Respiratory Distress Syndrome 1 1
Cardiac Arrest 1 1
Airway Obstruction 1 1
Apnea 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Ecchymosis 1 1
Extravasation 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 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 I Feb-25-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
6 Santanello Surgical LLC II Aug-09-2019
7 Teleflex Medical II Feb-16-2019
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