Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
tube, tracheostomy (w/wo connector)
Product Code
BTO
Regulation Number
868.5800
Device Class
2
Premarket Reviews
Manufacturer
Decision
SMITHS MEDICAL ADS, INC.
SUBSTANTIALLY EQUIVALENT
1
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
162
162
2019
87
87
2020
112
112
2021
199
199
2022
771
771
2023
159
159
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
187
187
Inflation Problem
144
144
Gas/Air Leak
142
142
Break
96
96
Detachment of Device or Device Component
93
93
Connection Problem
52
52
Crack
47
47
Disconnection
46
46
Defective Component
45
45
Component Missing
38
38
Fluid/Blood Leak
38
38
Material Split, Cut or Torn
36
36
Separation Problem
27
27
Contamination /Decontamination Problem
24
24
Device Markings/Labelling Problem
23
23
Defective Device
23
23
Use of Device Problem
23
23
Material Puncture/Hole
23
23
Device Damaged Prior to Use
21
21
Obstruction of Flow
21
21
Material Integrity Problem
20
20
Accessory Incompatible
20
20
Air Leak
19
19
Human-Device Interface Problem
19
19
Material Deformation
19
19
Deflation Problem
18
18
Incomplete or Missing Packaging
18
18
Material Separation
17
17
Tear, Rip or Hole in Device Packaging
14
14
Inadequacy of Device Shape and/or Size
14
14
Fracture
14
14
Material Discolored
14
14
Decrease in Pressure
13
13
Suction Problem
13
13
Gel Leak
11
11
Mechanical Problem
11
11
Insufficient Information
11
11
Unintended Deflation
11
11
Moisture or Humidity Problem
10
10
Pressure Problem
10
10
Patient Device Interaction Problem
9
9
Loose or Intermittent Connection
9
9
Nonstandard Device
9
9
Difficult to Remove
8
8
Difficult to Insert
8
8
Material Twisted/Bent
8
8
Noise, Audible
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Device Dislodged or Dislocated
7
7
Expiration Date Error
6
6
Deformation Due to Compressive Stress
6
6
Material Too Soft/Flexible
6
6
Physical Resistance/Sticking
6
6
Material Fragmentation
6
6
Material Rupture
6
6
Problem with Sterilization
5
5
Labelling, Instructions for Use or Training Problem
5
5
Degraded
5
5
Complete Blockage
5
5
Premature Separation
5
5
Packaging Problem
5
5
Positioning Problem
5
5
Optical Discoloration
4
4
Contamination of Device Ingredient or Reagent
4
4
Unsealed Device Packaging
4
4
Product Quality Problem
3
3
Sticking
3
3
Improper or Incorrect Procedure or Method
3
3
Failure to Deliver
3
3
Partial Blockage
3
3
Patient-Device Incompatibility
3
3
Separation Failure
3
3
Infusion or Flow Problem
3
3
Inaccurate Information
3
3
Unexpected Color
2
2
Failure to Deflate
2
2
Difficult to Advance
2
2
Device Operates Differently Than Expected
2
2
Failure to Disconnect
2
2
Malposition of Device
2
2
Blocked Connection
2
2
Adverse Event Without Identified Device or Use Problem
2
2
No Pressure
2
2
Mechanical Jam
2
2
Torn Material
2
2
Appropriate Term/Code Not Available
2
2
Misassembled
2
2
Moisture Damage
2
2
Dull, Blunt
2
2
Insufficient Flow or Under Infusion
2
2
Material Perforation
2
2
Device Difficult to Setup or Prepare
2
2
Material Too Rigid or Stiff
2
2
Unable to Obtain Readings
2
2
Pumping Stopped
1
1
Particulates
1
1
Occlusion Within Device
1
1
Stretched
1
1
Tidal Volume Fluctuations
1
1
Failure to Unfold or Unwrap
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
943
943
No Consequences Or Impact To Patient
198
198
Insufficient Information
114
114
No Known Impact Or Consequence To Patient
43
43
No Information
33
34
Extubate
30
30
Decreased Respiratory Rate
29
29
Low Oxygen Saturation
18
18
Airway Obstruction
17
17
No Patient Involvement
14
14
No Code Available
11
11
Dyspnea
10
10
Hemorrhage/Bleeding
8
8
Unintended Extubation
8
8
Hypoxia
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Foreign Body In Patient
4
4
Death
4
4
Tissue Damage
3
3
Abrasion
3
3
Respiratory Distress
3
3
Hypoventilation
3
3
Patient Problem/Medical Problem
3
3
Respiratory Insufficiency
3
3
Cardiac Arrest
3
3
Pneumonia
3
3
Pneumothorax
2
2
Fistula
2
2
Laceration(s) of Esophagus
2
2
Device Embedded In Tissue or Plaque
2
2
Pain
2
2
Blister
2
2
Fever
2
2
Swelling/ Edema
2
2
Respiratory Failure
2
2
Failure of Implant
2
2
Aspiration/Inhalation
2
2
Brain Injury
2
2
Confusion/ Disorientation
1
1
Diminished Pulse Pressure
1
1
Bradycardia
1
1
Hematemesis
1
1
Swelling
1
1
Thrombosis
1
1
Ventricular Tachycardia
1
1
Infiltration into Tissue
1
1
Hypovolemic Shock
1
1
Ulcer
1
1
Ventilator Dependent
1
1
Myocardial Hypertrophy
1
1
Chemosis
1
1
Skin Inflammation
1
1
Diaphoresis
1
1
Hypersensitivity/Allergic reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Apnea
1
1
Cardiovascular Insufficiency
1
1
Pulmonary Edema
1
1
Obstruction/Occlusion
1
1
Perforation
1
1
Urethral Stenosis/Stricture
1
1
Needle Stick/Puncture
1
1
Loss Of Pulse
1
1
Blood Loss
1
1
Granuloma
1
1
Unspecified Infection
1
1
Chest Pain
1
1
Ventricular Fibrillation
1
1
Discomfort
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smiths Medical ASD Inc.
II
Jun-04-2019
2
Smiths Medical ASD Inc.
II
Jun-07-2018
-
-