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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 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 151 151
Suction Failure 146 146
Disconnection 97 97
Gas/Air Leak 94 94
Break 84 84
Material Integrity Problem 55 55
Physical Resistance/Sticking 30 30
Detachment of Device or Device Component 26 26
Material Split, Cut or Torn 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Crack 12 12
Inflation Problem 11 11
Obstruction of Flow 11 11
Fluid/Blood Leak 10 10
Leak/Splash 9 9
Loose or Intermittent Connection 9 9
Use of Device Problem 9 9
Defective Component 8 8
Nonstandard Device 8 8
Material Twisted/Bent 8 8
Material Separation 7 7
Mechanical Problem 6 6
Defective Device 6 6
Increase in Suction 5 5
Retraction Problem 5 5
Decrease in Suction 5 5
Backflow 5 5
Difficult to Remove 4 4
Material Rupture 4 4
Difficult to Insert 4 4
Tidal Volume Fluctuations 4 4
Component Missing 4 4
Malposition of Device 4 4
Difficult to Advance 4 4
Device Dislodged or Dislocated 4 4
Connection Problem 3 3
Delivered as Unsterile Product 3 3
Material Puncture/Hole 3 3
Deflation Problem 3 3
Excess Flow or Over-Infusion 3 3
Fracture 3 3
Material Fragmentation 3 3
Mechanical Jam 3 3
Pressure Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Missing Information 2 2
Insufficient Information 2 2
Entrapment of Device 2 2
Decoupling 2 2
Complete Blockage 2 2
Stretched 2 2
Device Damaged Prior to Use 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Open or Close 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Overfill 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1
Structural Problem 1 1
Failure to Advance 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Optical Obstruction 1 1
Output Problem 1 1
Packaging Problem 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Too Rigid or Stiff 1 1
Unsealed Device Packaging 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Misconnection 1 1
Contamination 1 1
Device Alarm System 1 1
Restricted Flow rate 1 1
Difficult to Flush 1 1
Activation Failure 1 1
Component Misassembled 1 1
Ejection Problem 1 1
No Apparent Adverse Event 1 1
Failure to Deflate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 259 259
Insufficient Information 204 204
No Consequences Or Impact To Patient 133 133
No Known Impact Or Consequence To Patient 80 80
Low Oxygen Saturation 77 77
Foreign Body In Patient 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
No Code Available 9 9
Bacterial Infection 9 9
Airway Obstruction 8 8
Bradycardia 8 8
Hypoventilation 8 8
Respiratory Insufficiency 8 8
Unspecified Respiratory Problem 6 6
Decreased Peak Expiratory Flow rate 6 6
Cardiac Arrest 6 6
Pneumonia 6 6
Respiratory Distress 5 5
Discomfort 5 5
No Patient Involvement 5 5
Hypoxia 4 4
Unspecified Infection 3 3
Aspiration/Inhalation 3 3
Apnea 3 3
Death 3 3
Arrhythmia 2 2
Low Blood Pressure/ Hypotension 2 2
Hemorrhage/Bleeding 2 2
No Information 2 2
Choking 1 1
Decreased Respiratory Rate 1 1
Abdominal Distention 1 1
Unspecified Kidney or Urinary Problem 1 1
Unintended Extubation 1 1
Unspecified Nervous System Problem 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Respiratory Arrest 1 1
Intracranial Hemorrhage 1 1
Chest Pain 1 1
Hypovolemic Shock 1 1
Erosion 1 1
Asphyxia 1 1
Headache 1 1
Hematoma 1 1
Inflammation 1 1
Pain 1 1
Tachycardia 1 1
Pneumothorax 1 1
Pulmonary Dysfunction 1 1
Ventilator Dependent 1 1
Laceration(s) of Esophagus 1 1
Extubate 1 1
Respiratory Tract Infection 1 1
Brain Injury 1 1
Stenosis 1 1
Distress 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 I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-29-2022
7 Medline Industries Inc II Oct-06-2020
8 Medline Industries Inc II Jul-28-2020
9 RESPIRATORY THERAPEUTICS GROUP LLC II Mar-05-2020
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