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TPLC
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Device
tube tracheostomy and tube cuff
Product Code
JOH
Regulation Number
868.5800
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
COVIDIEN
SUBSTANTIALLY EQUIVALENT
2
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
3
TRACOE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2017
441
441
2018
810
810
2019
1019
1019
2020
791
791
2021
1053
1053
2022
461
461
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inflation Problem
685
685
Leak/Splash
632
632
Gas Leak
484
484
Use of Device Problem
466
466
Break
233
233
Material Split, Cut or Torn
211
211
Defective Component
205
205
Disconnection
139
139
Crack
115
115
Fluid Leak
108
108
Material Integrity Problem
105
105
Inadequacy of Device Shape and/or Size
91
91
Material Puncture/Hole
80
80
Air Leak
77
77
Material Separation
76
76
Detachment of Device or Device Component
76
76
Defective Device
64
64
Human-Device Interface Problem
62
62
Connection Problem
60
60
Material Discolored
58
58
Appropriate Term/Code Not Available
55
55
Fracture
50
50
Material Rupture
50
50
Material Fragmentation
48
48
Deflation Problem
47
47
Mechanical Problem
47
47
Insufficient Information
43
43
Obstruction of Flow
41
41
Product Quality Problem
37
37
Output Problem
36
36
Material Deformation
33
33
Hole In Material
31
31
Burst Container or Vessel
31
31
Patient-Device Incompatibility
29
29
Deformation Due to Compressive Stress
25
25
Tear, Rip or Hole in Device Packaging
25
25
Component Missing
25
25
Manufacturing, Packaging or Shipping Problem
23
23
Device Markings/Labelling Problem
23
23
Physical Resistance/Sticking
23
23
Device Dislodged or Dislocated
22
22
Failure to Disconnect
22
22
Gel Leak
22
22
Loose or Intermittent Connection
22
22
Split
21
21
Adverse Event Without Identified Device or Use Problem
21
21
Infusion or Flow Problem
19
19
Difficult to Advance
19
19
Patient Device Interaction Problem
19
19
Pressure Problem
18
18
Decrease in Pressure
18
18
Difficult to Remove
17
17
Labelling, Instructions for Use or Training Problem
17
17
Contamination /Decontamination Problem
15
15
Suction Problem
15
15
Fitting Problem
15
15
Partial Blockage
14
14
Positioning Problem
13
13
Torn Material
12
12
Device Alarm System
12
12
Fungus in Device Environment
12
12
Improper or Incorrect Procedure or Method
11
11
Failure to Unfold or Unwrap
11
11
Separation Failure
11
11
Occlusion Within Device
11
11
Scratched Material
11
11
Noise, Audible
11
11
Separation Problem
10
10
Malposition of Device
10
10
Device Operates Differently Than Expected
10
10
Device Contaminated During Manufacture or Shipping
10
10
Naturally Worn
10
10
Material Twisted/Bent
10
10
Packaging Problem
9
9
Sharp Edges
8
8
Contamination of Device Ingredient or Reagent
8
8
Structural Problem
8
8
Contamination
8
8
Peeled/Delaminated
7
7
Material Too Rigid or Stiff
7
7
Failure to Advance
7
7
Material Perforation
7
7
Cut In Material
7
7
Installation-Related Problem
7
7
Activation, Positioning or SeparationProblem
6
6
Difficult to Open or Close
6
6
Device Damaged Prior to Use
6
6
Failure to Align
6
6
Degraded
6
6
Suction Failure
6
6
Fail-Safe Did Not Operate
6
6
Unintended Movement
6
6
Optical Discoloration
5
5
Premature Separation
5
5
Complete Blockage
5
5
False Alarm
5
5
Device Slipped
5
5
Stretched
5
5
Material Opacification
5
5
Difficult to Insert
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1138
1138
No Clinical Signs, Symptoms or Conditions
765
765
No Known Impact Or Consequence To Patient
618
618
Extubate
458
458
Unintended Extubation
409
409
Insufficient Information
286
286
No Information
264
264
No Patient Involvement
246
246
Low Oxygen Saturation
107
107
No Code Available
77
77
Respiratory Distress
61
61
Death
50
50
Airway Obstruction
45
45
Hypoxia
37
37
Blood Loss
36
36
Discomfort
30
30
Pain
28
28
Dyspnea
28
28
Hypoventilation
27
27
Injury
27
27
Unspecified Tissue Injury
24
24
Hemorrhage/Bleeding
19
19
Irritation
18
18
Inflammation
12
12
Tachycardia
12
12
Hemoptysis
12
12
Aspiration/Inhalation
12
12
Cardiac Arrest
11
11
Pneumothorax
10
10
Unspecified Infection
10
10
Distress
10
10
Ventilator Dependent
10
10
Anxiety
8
8
Respiratory Failure
8
8
Patient Problem/Medical Problem
8
8
Respiratory Insufficiency
8
8
Dysphasia
8
8
Pneumonia
7
7
Granuloma
7
7
Obstruction/Occlusion
7
7
Sudden Cardiac Death
6
6
Skin Inflammation/ Irritation
6
6
Fistula
6
6
Asphyxia
6
6
Bradycardia
5
5
Cyanosis
5
5
Laceration(s)
5
5
Skin Irritation
5
5
Unspecified Respiratory Problem
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Increased Respiratory Rate
5
5
Foreign Body In Patient
5
5
Pressure Sores
5
5
Bronchospasm
4
4
Swelling
4
4
Low Blood Pressure/ Hypotension
4
4
Erythema
4
4
Dysphagia/ Odynophagia
4
4
Hyperventilation
3
3
Pulmonary Emphysema
3
3
Cardiopulmonary Arrest
3
3
Bacterial Infection
3
3
Wound Dehiscence
3
3
Pleural Effusion
3
3
Decreased Respiratory Rate
3
3
Respiratory Acidosis
3
3
Ulcer
3
3
Complaint, Ill-Defined
3
3
Respiratory Tract Infection
3
3
Missing Value Reason
3
3
Convulsion/Seizure
2
2
Fluid Discharge
2
2
Not Applicable
2
2
Loss of consciousness
2
2
Stenosis
2
2
Skin Tears
2
2
Lethargy
2
2
Infiltration into Tissue
2
2
Local Reaction
2
2
Suffocation
2
2
Scar Tissue
2
2
Electrolyte Imbalance
2
2
Ulceration
2
2
Asthma
2
2
Apnea
2
2
Exposure to Body Fluids
2
2
Hypersensitivity/Allergic reaction
2
2
Foreign Body Reaction
2
2
Encephalopathy
1
1
Endocarditis
1
1
Non specific EKG/ECG Changes
1
1
Macular Edema
1
1
Fatigue
1
1
Fever
1
1
Purulent Discharge
1
1
Atrial Fibrillation
1
1
Abrasion
1
1
Adult Respiratory Distress Syndrome
1
1
Air Embolism
1
1
Ventricular Fibrillation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smiths Medical ASD Inc.
II
Jul-01-2021
2
Smiths Medical ASD Inc.
II
Feb-23-2021
3
Smiths Medical ASD Inc.
II
Dec-28-2020
4
Smiths Medical ASD Inc.
II
Sep-09-2020
5
Smiths Medical ASD Inc.
II
Jul-01-2020
6
Smiths Medical ASD Inc.
II
Sep-26-2017
7
Smiths Medical ASD Inc.
II
Mar-14-2017
8
Smiths Medical ASD, Inc.
II
Feb-09-2018
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