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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
2
TRACOE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
812
812
2019
1019
1019
2020
791
791
2021
1041
1041
2022
1633
1633
2023
1076
1076
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inflation Problem
990
990
Gas/Air Leak
890
890
Use of Device Problem
759
759
Leak/Splash
627
627
Defective Component
360
360
Material Split, Cut or Torn
341
341
Break
277
277
Connection Problem
211
211
Disconnection
163
163
Crack
137
137
Defective Device
132
132
Material Separation
122
122
Material Puncture/Hole
120
120
Fluid/Blood Leak
112
112
Inadequacy of Device Shape and/or Size
96
96
Detachment of Device or Device Component
92
92
Human-Device Interface Problem
89
89
Fracture
83
83
Appropriate Term/Code Not Available
81
81
Material Integrity Problem
76
76
Obstruction of Flow
74
74
Material Discolored
73
73
Insufficient Information
73
73
Physical Resistance/Sticking
73
73
Deflation Problem
59
59
Material Fragmentation
54
54
Material Rupture
53
53
Product Quality Problem
49
49
Device Markings/Labelling Problem
48
48
Patient-Device Incompatibility
46
46
Mechanical Problem
45
45
Labelling, Instructions for Use or Training Problem
42
42
Patient Device Interaction Problem
42
42
Component Missing
41
41
Air Leak
39
39
Output Problem
37
37
Material Deformation
36
36
Adverse Event Without Identified Device or Use Problem
34
34
Contamination
34
34
Tear, Rip or Hole in Device Packaging
27
27
Deformation Due to Compressive Stress
26
26
Burst Container or Vessel
26
26
Difficult to Advance
25
25
Contamination /Decontamination Problem
24
24
Failure to Disconnect
22
22
Gel Leak
22
22
Difficult to Remove
22
22
Difficult to Insert
21
21
Loose or Intermittent Connection
21
21
Fitting Problem
21
21
No Apparent Adverse Event
21
21
Unintended Deflation
21
21
Pressure Problem
19
19
Suction Problem
19
19
Device Dislodged or Dislocated
19
19
Decrease in Pressure
18
18
Partial Blockage
18
18
Material Twisted/Bent
17
17
Manufacturing, Packaging or Shipping Problem
17
17
Infusion or Flow Problem
16
16
Degraded
15
15
Separation Problem
15
15
Noise, Audible
14
14
Sharp Edges
13
13
Device-Device Incompatibility
13
13
Improper or Incorrect Procedure or Method
13
13
Failure to Unfold or Unwrap
13
13
Microbial Contamination of Device
13
13
Fungus in Device Environment
13
13
Device Contaminated at the User Facility
12
12
Positioning Problem
12
12
Device Contaminated During Manufacture or Shipping
12
12
Material Too Soft/Flexible
11
11
Incomplete or Inadequate Connection
11
11
Device Damaged Prior to Use
11
11
Nonstandard Device
11
11
Device Alarm System
10
10
Split
10
10
Contamination of Device Ingredient or Reagent
10
10
Separation Failure
10
10
Malposition of Device
10
10
Failure to Deflate
10
10
Failure to Seal
9
9
Scratched Material
9
9
Material Protrusion/Extrusion
9
9
Installation-Related Problem
9
9
Occlusion Within Device
9
9
Material Too Rigid or Stiff
8
8
Complete Blockage
8
8
Filling Problem
8
8
Stretched
8
8
Structural Problem
8
8
Peeled/Delaminated
7
7
Failure to Align
6
6
Short Fill
6
6
Material Perforation
6
6
Volume Accuracy Problem
6
6
Improper Flow or Infusion
6
6
Difficult to Open or Close
6
6
Activation, Positioning or Separation Problem
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2051
2051
No Consequences Or Impact To Patient
1014
1014
Unintended Extubation
951
951
Insufficient Information
594
594
No Known Impact Or Consequence To Patient
522
522
Extubate
377
377
No Information
244
244
No Patient Involvement
203
203
Low Oxygen Saturation
154
154
Decreased Respiratory Rate
77
77
No Code Available
72
72
Hypoventilation
67
67
Airway Obstruction
59
59
Respiratory Distress
53
53
Unspecified Tissue Injury
50
50
Hypoxia
46
46
Dyspnea
43
43
Respiratory Insufficiency
40
40
Pain
39
39
Hemorrhage/Bleeding
38
38
Discomfort
37
37
Blood Loss
34
34
Death
34
34
Tachycardia
25
25
Injury
25
25
Cardiac Arrest
21
21
Aspiration/Inhalation
18
18
Irritation
18
18
Inflammation
17
17
Respiratory Failure
17
17
Skin Inflammation/ Irritation
17
17
Hemoptysis
15
15
Unspecified Infection
14
14
Distress
13
13
Pneumothorax
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Foreign Body In Patient
11
11
Unspecified Respiratory Problem
11
11
Bradycardia
10
10
Increased Respiratory Rate
9
9
Obstruction/Occlusion
8
8
Respiratory Tract Infection
8
8
Ventilator Dependent
8
8
Pressure Sores
8
8
Anxiety
8
8
Dysphasia
8
8
Pneumonia
8
8
Granuloma
7
7
Patient Problem/Medical Problem
7
7
Fistula
6
6
Cyanosis
6
6
Asphyxia
5
5
Apnea
5
5
Laceration(s)
5
5
Low Blood Pressure/ Hypotension
5
5
Stenosis
5
5
Ulcer
5
5
Sore Throat
4
4
Irritability
4
4
Forced Expiratory Volume Decreased
4
4
Cardiovascular Insufficiency
4
4
Hyperventilation
4
4
Failure of Implant
4
4
Skin Irritation
4
4
Wound Dehiscence
4
4
Chest Pain
4
4
Bacterial Infection
4
4
Hypersensitivity/Allergic reaction
4
4
Dysphagia/ Odynophagia
4
4
Pulmonary Emphysema
4
4
Erythema
4
4
Swelling/ Edema
4
4
Localized Skin Lesion
3
3
Cardiopulmonary Arrest
3
3
Pleural Effusion
3
3
Cough
3
3
Respiratory Arrest
3
3
Device Embedded In Tissue or Plaque
3
3
Missing Value Reason
3
3
Tissue Breakdown
3
3
Respiratory Acidosis
3
3
Sudden Cardiac Death
3
3
Swelling
3
3
Skin Tears
2
2
Fluid Discharge
2
2
Not Applicable
2
2
Unspecified Heart Problem
2
2
Convulsion/Seizure
2
2
Perforation
2
2
Infiltration into Tissue
2
2
Suffocation
2
2
Ventricular Fibrillation
2
2
Pulmonary Edema
2
2
Rash
2
2
Local Reaction
2
2
Respiratory Distress Syndrome of Newborns
2
2
Exposure to Body Fluids
2
2
Abrasion
2
2
Asthma
2
2
High Blood Pressure/ Hypertension
2
2
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
9
Smiths Medical ASD, Inc.
II
Feb-09-2018
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