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TPLC
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Device
catheters, suction, tracheobronchial
Regulation Description
Tracheobronchial suction catheter.
Product Code
BSY
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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