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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
2014 42 42
2015 26 26
2016 61 61
2017 179 179
2018 161 161
2019 442 442
2020 187 187
2021 283 283
2022 221 221
2023 198 198
2024 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 423 423
Device Contamination with Chemical or Other Material 312 312
Suction Problem 219 219
Leak/Splash 165 165
Break 118 118
Detachment of Device or Device Component 84 84
Fluid/Blood Leak 72 72
Material Separation 67 67
Adverse Event Without Identified Device or Use Problem 47 47
Material Integrity Problem 40 40
Disconnection 34 34
Unraveled Material 30 30
Device Contaminated During Manufacture or Shipping 29 29
Use of Device Problem 20 20
Decrease in Suction 19 19
Detachment Of Device Component 19 19
Material Deformation 16 16
No Flow 16 16
Activation Problem 15 15
Appropriate Term/Code Not Available 14 14
Difficult to Remove 13 13
Contamination /Decontamination Problem 10 10
Suction Failure 10 10
Kinked 9 9
Entrapment of Device 9 9
Fracture 8 8
Material Frayed 8 8
Fitting Problem 8 8
Device Damaged Prior to Use 8 8
Packaging Problem 8 8
Insufficient Information 7 7
Device Operates Differently Than Expected 7 7
Crack 7 7
Delivered as Unsterile Product 6 6
Component Missing 6 6
Defective Component 6 6
Gas/Air Leak 6 6
Material Split, Cut or Torn 5 5
No Apparent Adverse Event 5 5
Material Puncture/Hole 5 5
Hole In Material 5 5
Loose or Intermittent Connection 5 5
Material Fragmentation 4 4
Component Falling 4 4
Improper or Incorrect Procedure or Method 4 4
Material Too Rigid or Stiff 4 4
Defective Device 4 4
Physical Resistance/Sticking 4 4
Tear, Rip or Hole in Device Packaging 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Twisted/Bent 3 3
Separation Problem 3 3
Device Or Device Fragments Location Unknown 3 3
Device Markings/Labelling Problem 3 3
Device Inoperable 3 3
Microbial Contamination of Device 3 3
Complete Blockage 3 3
Partial Blockage 3 3
Difficult to Insert 3 3
Migration or Expulsion of Device 2 2
Occlusion Within Device 2 2
Contamination 2 2
Backflow 2 2
Reflux within Device 2 2
Shelf Life Exceeded 2 2
Malposition of Device 2 2
Inaccurate Information 2 2
Sharp Edges 2 2
Output Problem 2 2
Difficult to Advance 2 2
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Mechanical Jam 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
Device Handling Problem 1 1
Noise, Audible 1 1
Air/Gas in Device 1 1
Patient-Device Incompatibility 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Failure to Advance 1 1
Failure to Disconnect 1 1
Connection Problem 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Device-Device Incompatibility 1 1
Smoking 1 1
Tip breakage 1 1
Material Perforation 1 1
Valve(s), failure of 1 1
Air Leak 1 1
Burst Container or Vessel 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 691 691
No Consequences Or Impact To Patient 410 410
No Patient Involvement 344 344
No Known Impact Or Consequence To Patient 175 175
Pneumothorax 36 36
Foreign Body In Patient 35 35
No Code Available 34 34
Insufficient Information 34 34
No Information 27 27
Not Applicable 11 11
Swelling 9 9
Pain 9 9
Unspecified Infection 8 8
Hemorrhage/Bleeding 8 8
Death 6 6
Seroma 6 6
Internal Organ Perforation 5 5
Injury 5 5
Bacterial Infection 5 5
Bradycardia 5 5
Failure to Anastomose 5 5
Inflammation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Device Embedded In Tissue or Plaque 4 4
Hematoma 4 4
Airway Obstruction 4 4
Pleural Effusion 4 4
Pneumonia 4 4
Cardiac Tamponade 4 4
Reaction 4 4
Low Oxygen Saturation 3 3
Dyspnea 3 3
Fistula 3 3
Laceration(s) 3 3
Necrosis 3 3
Air Embolism 3 3
Pulmonary Emphysema 3 3
Chest Pain 2 2
Cardiac Arrest 2 2
Abdominal Pain 2 2
Respiratory Failure 2 2
Cardiac Perforation 2 2
Impaired Healing 2 2
Loss of consciousness 2 2
Obstruction/Occlusion 2 2
Respiratory Distress 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 2 2
Unspecified Respiratory Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Shock 1 1
Tachycardia 1 1
Needle Stick/Puncture 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Alteration In Body Temperature 1 1
Partial thickness (Second Degree) Burn 1 1
Vascular Dissection 1 1
Skin Tears 1 1
Lethargy 1 1
Surgical procedure, additional 1 1
Pseudoaneurysm 1 1
Increased Respiratory Rate 1 1
Organ Dehiscence 1 1
Abrasion 1 1
Adult Respiratory Distress Syndrome 1 1
Wound Dehiscence 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Atrial Fibrillation 1 1
Cardiopulmonary Arrest 1 1
Exposure to Body Fluids 1 1
Ecchymosis 1 1
Edema 1 1
Electro-Mechanical Dissociation 1 1
Extravasation 1 1
Fever 1 1
Hemothorax 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Paralysis 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 Customed, Inc II Apr-14-2016
5 Customed, Inc II Sep-03-2015
6 Invuity, Inc. II Oct-03-2012
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
9 Santanello Surgical LLC II Aug-09-2019
10 Teleflex Medical II Feb-16-2019
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