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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
Product CodeBSY
Regulation Number 868.6810
Device Class 1

MDR Year MDR Reports MDR Events
2019 121 121
2020 149 149
2021 63 63
2022 309 309
2023 198 198
2024 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 151 151
Suction Failure 148 148
Gas/Air Leak 106 106
Disconnection 102 102
Break 85 85
Material Integrity Problem 69 69
Physical Resistance/Sticking 30 30
Detachment of Device or Device Component 26 26
Material Split, Cut or Torn 21 21
Inflation Problem 20 20
Adverse Event Without Identified Device or Use Problem 18 18
Decrease in Suction 15 15
Fluid/Blood Leak 15 15
Use of Device Problem 14 14
Excess Flow or Over-Infusion 13 13
Crack 13 13
Obstruction of Flow 11 11
Unintended Deflation 10 10
Leak/Splash 10 10
Loose or Intermittent Connection 9 9
Material Twisted/Bent 8 8
Nonstandard Device 8 8
Defective Component 8 8
Backflow 7 7
Material Separation 7 7
Complete Blockage 7 7
Mechanical Problem 6 6
Increase in Suction 6 6
Defective Device 6 6
Retraction Problem 5 5
Material Too Soft/Flexible 5 5
Difficult to Advance 5 5
Difficult to Remove 4 4
Malposition of Device 4 4
Device Dislodged or Dislocated 4 4
Material Rupture 4 4
Component Missing 4 4
Difficult to Insert 4 4
Tidal Volume Fluctuations 4 4
Material Puncture/Hole 3 3
Material Fragmentation 3 3
Connection Problem 3 3
Delivered as Unsterile Product 3 3
Pressure Problem 3 3
Fracture 3 3
Difficult to Open or Remove Packaging Material 3 3
Deflation Problem 3 3
Mechanical Jam 3 3
Tear, Rip or Hole in Device Packaging 2 2
Inadequacy of Device Shape and/or Size 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 300 300
Insufficient Information 225 225
No Consequences Or Impact To Patient 133 133
No Known Impact Or Consequence To Patient 80 80
Low Oxygen Saturation 79 79
Foreign Body In Patient 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Bacterial Infection 9 9
No Code Available 9 9
Airway Obstruction 8 8
Hypoventilation 8 8
Respiratory Insufficiency 8 8
Bradycardia 8 8
Unspecified Respiratory Problem 6 6
Hypoxia 6 6
Decreased Peak Expiratory Flow rate 6 6
Pneumonia 6 6
Cardiac Arrest 6 6
Respiratory Distress 5 5
Discomfort 5 5
No Patient Involvement 5 5
Unspecified Infection 3 3
Apnea 3 3
Death 3 3
Aspiration/Inhalation 3 3
Low Blood Pressure/ Hypotension 2 2
Hemorrhage/Bleeding 2 2
Choking 2 2
No Information 2 2
Arrhythmia 2 2
Chest Pain 1 1
Intracranial Hemorrhage 1 1
Respiratory Tract Infection 1 1
Vomiting 1 1
Asphyxia 1 1
Unspecified Nervous System Problem 1 1
Pain 1 1
Unspecified Kidney or Urinary Problem 1 1
Laceration(s) of Esophagus 1 1
Hematoma 1 1
Stenosis 1 1
Tachycardia 1 1
Cough 1 1
Inflammation 1 1
Abdominal Distention 1 1
Erosion 1 1
Brain Injury 1 1
Extubate 1 1
Headache 1 1
Respiratory Arrest 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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