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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
2017 179 179
2018 161 161
2019 442 442
2020 187 187
2021 283 283
2022 136 136

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 299 299
Obstruction of Flow 273 273
Suction Problem 214 214
Leak/Splash 86 86
Break 80 80
Detachment of Device or Device Component 73 73
Material Separation 59 59
Adverse Event Without Identified Device or Use Problem 41 41
Disconnection 32 32
Fluid Leak 31 31
Device Contaminated During Manufacture or Shipping 21 21
Decrease in Suction 18 18
Unraveled Material 16 16
Use of Device Problem 14 14
Detachment Of Device Component 11 11
Activation Problem 11 11
Appropriate Term/Code Not Available 10 10
Material Integrity Problem 10 10
Material Deformation 9 9
Contamination /Decontamination Problem 9 9
Entrapment of Device 9 9
Kinked 8 8
Device Damaged Prior to Use 8 8
Fitting Problem 7 7
Material Frayed 7 7
Difficult to Remove 7 7
Fracture 6 6
Component Missing 6 6
No Flow 6 6
Suction Failure 6 6
Hole In Material 5 5
Crack 5 5
Loose or Intermittent Connection 5 5
Delivered as Unsterile Product 4 4
Material Too Rigid or Stiff 4 4
No Apparent Adverse Event 4 4
Insufficient Information 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 3 3
Material Puncture/Hole 3 3
Device Markings/Labelling Problem 3 3
Device Operates Differently Than Expected 3 3
Defective Component 3 3
Gas Leak 3 3
Difficult to Advance 2 2
Material Twisted/Bent 2 2
Output Problem 2 2
Packaging Problem 2 2
Reflux within Device 2 2
Improper or Incorrect Procedure or Method 2 2
Shelf Life Exceeded 2 2
Component Falling 2 2
Contamination 2 2
Complete Blockage 2 2
Backflow 2 2
Partial Blockage 2 2
Sharp Edges 2 2
Separation Problem 2 2
Inaccurate Information 2 2
Air/Gas in Device 1 1
Noise, Audible 1 1
Collapse 1 1
Air Leak 1 1
Material Fragmentation 1 1
Smoking 1 1
Occlusion Within Device 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Mechanical Problem 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Material Perforation 1 1
Failure to Advance 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Blocked Connection 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 398 398
No Consequences Or Impact To Patient 358 358
No Patient Involvement 338 338
No Known Impact Or Consequence To Patient 128 128
No Code Available 30 30
Foreign Body In Patient 29 29
No Information 23 23
Pneumothorax 23 23
Insufficient Information 20 20
Not Applicable 11 11
Swelling 9 9
Pain 8 8
Hemorrhage/Bleeding 6 6
Unspecified Infection 6 6
Failure to Anastomose 5 5
Death 5 5
Seroma 5 5
Reaction 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Inflammation 4 4
Pleural Effusion 4 4
Pneumonia 4 4
Laceration(s) 3 3
Necrosis 3 3
Internal Organ Perforation 3 3
Fistula 3 3
Hematoma 3 3
Bradycardia 3 3
Air Embolism 3 3
Device Embedded In Tissue or Plaque 3 3
Injury 3 3
Impaired Healing 2 2
Obstruction/Occlusion 2 2
Bacterial Infection 2 2
Chest Pain 2 2
Dyspnea 2 2
Respiratory Distress 2 2
Tachycardia 1 1
Paralysis 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Edema 1 1
Extravasation 1 1
Fever 1 1
Cardiac Arrest 1 1
Airway Obstruction 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Atrial Fibrillation 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Adult Respiratory Distress Syndrome 1 1
Needle Stick/Puncture 1 1
Cardiac Perforation 1 1
Pseudoaneurysm 1 1
Cardiac Tamponade 1 1
Distress 1 1
Partial thickness (Second Degree) Burn 1 1
Vascular Dissection 1 1
Loss of consciousness 1 1
Unspecified Respiratory Problem 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Mar-21-2019
2 Cook Inc. II Nov-21-2019
3 Santanello Surgical LLC II Aug-09-2019
4 Teleflex Medical II Feb-16-2019
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