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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheters, suction, tracheobronchial
Regulation Description Tracheobronchial suction catheter.
Product CodeBSY
Regulation Number 868.6810
Device Class 1

MDR Year MDR Reports MDR Events
2021 63 63
2022 309 309
2023 198 198
2024 210 210
2025 165 165

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Failure 147 147
Suction Problem 135 135
Break 127 127
Gas/Air Leak 120 120
Material Integrity Problem 82 82
Material Split, Cut or Torn 43 43
Use of Device Problem 35 35
Disconnection 20 20
Mechanical Problem 20 20
Inflation Problem 19 19
Fluid/Blood Leak 17 17
Connection Problem 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Decrease in Suction 15 15
Leak/Splash 14 14
Excess Flow or Over-Infusion 14 14
Crack 13 13
Physical Resistance/Sticking 12 12
Unintended Deflation 10 10
Complete Blockage 9 9
Material Puncture/Hole 9 9
Detachment of Device or Device Component 9 9
Increase in Suction 8 8
Loose or Intermittent Connection 8 8
Material Separation 8 8
Obstruction of Flow 8 8
Nonstandard Device 7 7
Defective Component 7 7
Inadequacy of Device Shape and/or Size 7 7
Material Twisted/Bent 7 7
Backflow 7 7
Infusion or Flow Problem 6 6
Material Too Soft/Flexible 5 5
Device Dislodged or Dislocated 4 4
Failure to Advance 4 4
Fracture 4 4
Material Rupture 4 4
Difficult to Insert 4 4
Device Damaged Prior to Use 4 4
Difficult to Remove 4 4
Defective Device 4 4
Mechanical Jam 3 3
Appropriate Term/Code Not Available 3 3
Component Missing 3 3
Patient Device Interaction Problem 3 3
Difficult to Advance 3 3
Insufficient Information 3 3
Tidal Volume Fluctuations 3 3
Difficult to Open or Remove Packaging Material 3 3
Contamination 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 488 488
Insufficient Information 256 256
Low Oxygen Saturation 82 82
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Foreign Body In Patient 24 24
Respiratory Insufficiency 10 10
Bacterial Infection 9 9
Airway Obstruction 8 8
Hypoventilation 8 8
Bradycardia 7 7
Discomfort 7 7
Unspecified Respiratory Problem 6 6
Hypoxia 6 6
Decreased Peak Expiratory Flow rate 6 6
No Consequences Or Impact To Patient 5 5
Pneumonia 4 4
Cardiac Arrest 4 4
Vomiting 3 3
Increased Respiratory Rate 3 3
Unspecified Infection 3 3
Choking 2 2
Aspiration/Inhalation 2 2
Tachycardia 2 2
Arrhythmia 2 2
Unspecified Nervous System Problem 1 1
Intracranial Hemorrhage 1 1
Laceration(s) of Esophagus 1 1
Abdominal Distention 1 1
Respiratory Tract Infection 1 1
Pain 1 1
Unspecified Kidney or Urinary Problem 1 1
Hematoma 1 1
Cough 1 1
Respiratory Arrest 1 1
Brain Injury 1 1
Pneumothorax 1 1
Apnea 1 1
Hemorrhage/Bleeding 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Hypovolemic Shock 1 1
Ventilator Dependent 1 1
Decreased Respiratory Rate 1 1
Unintended Extubation 1 1
Distress 1 1
Aspiration Pneumonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. I Apr-16-2025
2 Avanos Medical, Inc. II Nov-21-2023
3 Avanos Medical, Inc. I Mar-13-2023
4 Avanos Medical, Inc. II Mar-31-2022
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-29-2022
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