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

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Failure 150 150
Suction Problem 144 144
Gas/Air Leak 116 116
Break 90 90
Material Integrity Problem 75 75
Disconnection 68 68
Use of Device Problem 26 26
Material Split, Cut or Torn 20 20
Inflation Problem 19 19
Detachment of Device or Device Component 18 18
Crack 18 18
Fluid/Blood Leak 17 17
Physical Resistance/Sticking 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Decrease in Suction 14 14
Excess Flow or Over-Infusion 13 13
Obstruction of Flow 12 12
Leak/Splash 11 11
Unintended Deflation 10 10
Complete Blockage 9 9
Mechanical Problem 8 8
Nonstandard Device 8 8
Material Separation 8 8
Defective Component 8 8
Material Twisted/Bent 7 7
Backflow 7 7
Loose or Intermittent Connection 6 6
Defective Device 6 6
Material Too Soft/Flexible 5 5
Connection Problem 5 5
Retraction Problem 5 5
Increase in Suction 5 5
Difficult to Advance 5 5
Difficult to Remove 4 4
Malposition of Device 4 4
Device Dislodged or Dislocated 4 4
Device Damaged Prior to Use 4 4
Component Missing 4 4
Material Rupture 4 4
Mechanical Jam 3 3
Difficult to Open or Remove Packaging Material 3 3
Incomplete or Inadequate Connection 3 3
Appropriate Term/Code Not Available 3 3
Failure to Advance 3 3
Fracture 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Puncture/Hole 3 3
Insufficient Information 3 3
Material Fragmentation 3 3
Difficult to Insert 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 371 371
Insufficient Information 240 240
No Consequences Or Impact To Patient 89 89
Low Oxygen Saturation 74 74
No Known Impact Or Consequence To Patient 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Foreign Body In Patient 26 26
Bacterial Infection 9 9
Respiratory Insufficiency 9 9
Hypoventilation 8 8
Airway Obstruction 8 8
Hypoxia 8 8
Bradycardia 8 8
No Code Available 7 7
Decreased Peak Expiratory Flow rate 6 6
Unspecified Respiratory Problem 6 6
Discomfort 6 6
Cardiac Arrest 5 5
Respiratory Distress 4 4
Unspecified Infection 3 3
Arrhythmia 2 2
Abdominal Distention 2 2
Aspiration/Inhalation 2 2
Increased Respiratory Rate 2 2
Choking 2 2
Aspiration Pneumonitis 1 1
Distress 1 1
Unintended Extubation 1 1
Decreased Respiratory Rate 1 1
Ventilator Dependent 1 1
Hemorrhage/Bleeding 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Headache 1 1
Extubate 1 1
Cough 1 1
Tachycardia 1 1
Pneumonia 1 1
Unspecified Kidney or Urinary Problem 1 1
Pain 1 1
Asphyxia 1 1
Vomiting 1 1
Respiratory Tract Infection 1 1
Chest Pain 1 1
No Patient Involvement 1 1
Intracranial Hemorrhage 1 1
Unspecified Nervous System Problem 1 1
Laceration(s) of Esophagus 1 1
Hematoma 1 1
Inflammation 1 1
No Information 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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