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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
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
2
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
1
TRACOE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1019
1019
2020
791
791
2021
1041
1041
2022
1633
1633
2023
1233
1233
2024
243
243
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
972
972
Use of Device Problem
876
876
Inflation Problem
844
844
Leak/Splash
504
504
Defective Component
375
375
Material Split, Cut or Torn
327
327
Break
238
238
Connection Problem
211
211
Disconnection
150
150
Crack
135
135
Defective Device
122
122
Material Separation
115
115
Fluid/Blood Leak
111
111
Material Puncture/Hole
110
110
Appropriate Term/Code Not Available
89
89
Detachment of Device or Device Component
85
85
Insufficient Information
84
84
Fracture
82
82
Physical Resistance/Sticking
76
76
Inadequacy of Device Shape and/or Size
75
75
Human-Device Interface Problem
70
70
Material Discolored
67
67
Obstruction of Flow
66
66
Material Integrity Problem
58
58
Device Markings/Labelling Problem
52
52
Deflation Problem
51
51
Material Fragmentation
50
50
Material Rupture
48
48
Labelling, Instructions for Use or Training Problem
45
45
Patient-Device Incompatibility
43
43
Mechanical Problem
42
42
Patient Device Interaction Problem
42
42
Contamination
33
33
Component Missing
32
32
Material Deformation
31
31
Adverse Event Without Identified Device or Use Problem
30
30
Product Quality Problem
29
29
Difficult to Advance
26
26
Tear, Rip or Hole in Device Packaging
26
26
Unintended Deflation
25
25
Deformation Due to Compressive Stress
24
24
Contamination /Decontamination Problem
21
21
Difficult to Insert
21
21
No Apparent Adverse Event
21
21
Gel Leak
20
20
Loose or Intermittent Connection
18
18
Difficult to Remove
18
18
Material Twisted/Bent
18
18
Separation Problem
18
18
Microbial Contamination of Device
17
17
Fitting Problem
16
16
Device Dislodged or Dislocated
16
16
Output Problem
16
16
Device-Device Incompatibility
15
15
Pressure Problem
15
15
Infusion or Flow Problem
14
14
Failure to Unfold or Unwrap
14
14
Degraded
13
13
Suction Problem
13
13
Fungus in Device Environment
13
13
Device Contaminated During Manufacture or Shipping
12
12
Manufacturing, Packaging or Shipping Problem
12
12
Partial Blockage
12
12
Device Contaminated at the User Facility
12
12
Material Too Soft/Flexible
11
11
Incomplete or Inadequate Connection
11
11
Nonstandard Device
11
11
Improper or Incorrect Procedure or Method
11
11
Decrease in Pressure
10
10
Device Alarm System
10
10
Failure to Deflate
10
10
Failure to Seal
9
9
Installation-Related Problem
9
9
Malposition of Device
8
8
Scratched Material
8
8
Device Damaged Prior to Use
8
8
Structural Problem
8
8
Separation Failure
8
8
Burst Container or Vessel
8
8
Filling Problem
8
8
Material Too Rigid or Stiff
8
8
Stretched
7
7
Complete Blockage
7
7
Volume Accuracy Problem
6
6
Short Fill
6
6
Peeled/Delaminated
6
6
Material Perforation
6
6
Optical Discoloration
6
6
Material Protrusion/Extrusion
6
6
Fail-Safe Did Not Operate
6
6
Unexpected Color
6
6
Sharp Edges
6
6
Packaging Problem
5
5
Noise, Audible
5
5
Missing Information
5
5
Therapeutic or Diagnostic Output Failure
5
5
Unintended Movement
5
5
Contamination of Device Ingredient or Reagent
5
5
Activation, Positioning or Separation Problem
5
5
Overfill
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2252
2252
Unintended Extubation
1093
1093
No Consequences Or Impact To Patient
815
815
Insufficient Information
645
645
Extubate
264
264
No Information
217
217
No Known Impact Or Consequence To Patient
207
207
Low Oxygen Saturation
158
158
No Patient Involvement
147
147
Hypoventilation
80
80
Decreased Respiratory Rate
77
77
Airway Obstruction
59
59
No Code Available
54
54
Unspecified Tissue Injury
51
51
Dyspnea
51
51
Respiratory Insufficiency
41
41
Hemorrhage/Bleeding
40
40
Respiratory Distress
39
39
Hypoxia
35
35
Death
31
31
Pain
28
28
Discomfort
28
28
Tachycardia
23
23
Skin Inflammation/ Irritation
20
20
Cardiac Arrest
18
18
Inflammation
17
17
Irritation
16
16
Respiratory Failure
15
15
Distress
15
15
Injury
14
14
Unspecified Infection
14
14
Aspiration/Inhalation
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
13
13
Unspecified Respiratory Problem
12
12
Pneumothorax
12
12
Pneumonia
11
11
Failure of Implant
9
9
Bradycardia
9
9
Foreign Body In Patient
9
9
Respiratory Tract Infection
8
8
Pressure Sores
8
8
Dysphasia
8
8
Anxiety
7
7
Increased Respiratory Rate
7
7
Obstruction/Occlusion
7
7
Bacterial Infection
6
6
Hemoptysis
6
6
Fistula
6
6
Cyanosis
6
6
Dysphagia/ Odynophagia
5
5
Granuloma
5
5
Wound Dehiscence
5
5
Stenosis
5
5
Ulcer
5
5
Ventilator Dependent
5
5
Patient Problem/Medical Problem
5
5
Cough
5
5
Swelling/ Edema
5
5
Cardiovascular Insufficiency
4
4
Sore Throat
4
4
Irritability
4
4
Forced Expiratory Volume Decreased
4
4
Apnea
4
4
Chest Pain
4
4
Hypersensitivity/Allergic reaction
4
4
Asphyxia
4
4
Pulmonary Emphysema
4
4
Erythema
4
4
Low Blood Pressure/ Hypotension
4
4
Laceration(s)
4
4
Hyperventilation
3
3
Skin Irritation
3
3
Respiratory Acidosis
3
3
Sudden Cardiac Death
3
3
Blood Loss
3
3
Respiratory Arrest
3
3
Tissue Breakdown
3
3
Localized Skin Lesion
3
3
Unintended Radiation Exposure
2
2
Fluid Discharge
2
2
Device Embedded In Tissue or Plaque
2
2
Unspecified Heart Problem
2
2
Convulsion/Seizure
2
2
Skin Tears
2
2
Choking
2
2
Local Reaction
2
2
Viral Infection
2
2
Swelling
2
2
Respiratory Distress Syndrome of Newborns
2
2
Pulmonary Edema
2
2
Ventricular Fibrillation
2
2
Perforation
2
2
Pleural Effusion
2
2
Fatigue
2
2
High Blood Pressure/ Hypertension
2
2
Asthma
2
2
Abrasion
2
2
Abscess
1
1
Adult Respiratory Distress Syndrome
1
1
Air Embolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Incorporated
I
May-10-2023
2
Covidien
I
Apr-19-2023
3
Smiths Medical ASD Inc.
II
Oct-31-2023
4
Smiths Medical ASD Inc.
II
Jul-01-2021
5
Smiths Medical ASD Inc.
II
Feb-23-2021
6
Smiths Medical ASD Inc.
II
Dec-28-2020
7
Smiths Medical ASD Inc.
II
Sep-09-2020
8
Smiths Medical ASD Inc.
II
Jul-01-2020
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