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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
2020 149 149
2021 63 63
2022 309 309
2023 198 198
2024 211 211
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Failure 150 150
Suction Problem 145 145
Gas/Air Leak 119 119
Break 94 94
Material Integrity Problem 75 75
Disconnection 68 68
Use of Device Problem 26 26
Material Split, Cut or Torn 23 23
Inflation Problem 19 19
Detachment of Device or Device Component 18 18
Crack 18 18
Physical Resistance/Sticking 17 17
Fluid/Blood Leak 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Decrease in Suction 15 15
Excess Flow or Over-Infusion 13 13
Obstruction of Flow 12 12
Leak/Splash 12 12
Loose or Intermittent Connection 10 10
Unintended Deflation 10 10
Material Separation 9 9
Nonstandard Device 9 9
Complete Blockage 9 9
Mechanical Problem 8 8
Defective Component 8 8
Backflow 7 7
Material Twisted/Bent 7 7
Defective Device 6 6
Connection Problem 6 6
Increase in Suction 5 5
Difficult to Advance 5 5
Retraction Problem 5 5
Material Too Soft/Flexible 5 5
Difficult to Remove 4 4
Material Rupture 4 4
Component Missing 4 4
Device Damaged Prior to Use 4 4
Device Dislodged or Dislocated 4 4
Malposition of Device 4 4
Failure to Advance 3 3
Insufficient Information 3 3
Material Fragmentation 3 3
Difficult to Insert 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Puncture/Hole 3 3
Mechanical Jam 3 3
Tidal Volume Fluctuations 3 3
Incomplete or Inadequate Connection 3 3
Difficult to Open or Remove Packaging Material 3 3
Fracture 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 379 379
Insufficient Information 243 243
No Consequences Or Impact To Patient 89 89
Low Oxygen Saturation 78 78
No Known Impact Or Consequence To Patient 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Foreign Body In Patient 26 26
Respiratory Insufficiency 9 9
Bacterial Infection 9 9
Airway Obstruction 8 8
Hypoventilation 8 8
Hypoxia 8 8
Bradycardia 8 8
No Code Available 7 7
Discomfort 6 6
Unspecified Respiratory Problem 6 6
Decreased Peak Expiratory Flow rate 6 6
Cardiac Arrest 5 5
Respiratory Distress 4 4
Unspecified Infection 3 3
Aspiration/Inhalation 2 2
Abdominal Distention 2 2
Increased Respiratory Rate 2 2
Choking 2 2
Arrhythmia 2 2
Hypovolemic Shock 1 1
Inflammation 1 1
Vomiting 1 1
Respiratory Tract Infection 1 1
Unintended Extubation 1 1
Intracranial Hemorrhage 1 1
Pneumonia 1 1
No Information 1 1
Aspiration Pneumonitis 1 1
Extubate 1 1
Pneumothorax 1 1
Respiratory Arrest 1 1
Decreased Respiratory Rate 1 1
Hematoma 1 1
Tachycardia 1 1
Brain Injury 1 1
Cough 1 1
Unspecified Nervous System Problem 1 1
Headache 1 1
Pulmonary Dysfunction 1 1
No Patient Involvement 1 1
Death 1 1
Unspecified Kidney or Urinary Problem 1 1
Asphyxia 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Nov-21-2023
2 Avanos Medical, Inc. I Mar-13-2023
3 Avanos Medical, Inc. II Mar-31-2022
4 Avanos Medical, Inc. II Jan-08-2020
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
8 Medline Industries Inc II Oct-06-2020
9 Medline Industries Inc II Jul-28-2020
10 RESPIRATORY THERAPEUTICS GROUP LLC II Mar-05-2020
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