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TPLC
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Device
tube, tracheal (w/wo connector)
Regulation Description
Tracheal tube.
Product Code
BTR
Regulation Number
868.5730
Device Class
2
Premarket Reviews
Manufacturer
Decision
BRYAN MEDICAL , INC.
SUBSTANTIALLY EQUIVALENT
1
BRYAN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
1
FLEXICARE MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
SALTER LABS, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1070
1070
2021
1329
1329
2022
1132
1132
2023
1331
1331
2024
1678
1678
2025
911
911
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
2264
2264
Use of Device Problem
1844
1844
Material Split, Cut or Torn
498
498
Inflation Problem
419
419
Defective Component
340
340
Disconnection
293
293
Leak/Splash
259
259
Connection Problem
190
190
Deflation Problem
149
149
Material Puncture/Hole
114
114
Material Integrity Problem
108
108
Detachment of Device or Device Component
107
107
Material Twisted/Bent
101
101
Material Rupture
86
86
Obstruction of Flow
82
82
Break
77
77
Insufficient Information
75
75
Unintended Deflation
72
72
Labelling, Instructions for Use or Training Problem
66
66
Fluid/Blood Leak
66
66
Appropriate Term/Code Not Available
63
63
Material Separation
58
58
Crack
54
54
Device Markings/Labelling Problem
52
52
Human-Device Interface Problem
47
47
Separation Problem
46
46
Contamination /Decontamination Problem
43
43
Deformation Due to Compressive Stress
41
41
Mechanical Problem
40
40
Pressure Problem
35
35
Defective Device
33
33
Material Deformation
30
30
Patient-Device Incompatibility
30
30
Physical Resistance/Sticking
25
25
Component Missing
25
25
Material Too Rigid or Stiff
23
23
Loose or Intermittent Connection
20
20
Component Incompatible
19
19
Inadequacy of Device Shape and/or Size
18
18
Decrease in Pressure
17
17
Tear, Rip or Hole in Device Packaging
16
16
Failure to Disconnect
16
16
Delivered as Unsterile Product
16
16
Burst Container or Vessel
16
16
Partial Blockage
15
15
Fitting Problem
15
15
Failure to Deflate
15
15
Fracture
14
14
Manufacturing, Packaging or Shipping Problem
14
14
Difficult to Remove
14
14
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3783
3783
Unintended Extubation
1704
1704
Insufficient Information
863
863
Extubate
335
335
No Consequences Or Impact To Patient
292
292
Low Oxygen Saturation
290
290
No Patient Involvement
170
170
Hypoventilation
105
105
No Known Impact Or Consequence To Patient
82
82
No Information
75
75
Unspecified Tissue Injury
72
72
Hypoxia
63
63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
44
44
Airway Obstruction
44
44
Cardiac Arrest
37
37
Hemorrhage/Bleeding
35
35
Decreased Respiratory Rate
33
33
Respiratory Insufficiency
32
32
Dyspnea
24
24
Swelling/ Edema
21
21
Unspecified Respiratory Problem
18
18
Respiratory Failure
18
18
Bradycardia
17
17
Respiratory Arrest
16
16
Pain
16
16
Pneumonia
14
14
Foreign Body In Patient
13
13
Aspiration/Inhalation
12
12
Pneumothorax
10
10
Death
10
10
Low Blood Pressure/ Hypotension
9
9
Obstruction/Occlusion
9
9
Injury
9
9
Adult Respiratory Distress Syndrome
7
7
Increased Respiratory Rate
7
7
Pulmonary Emphysema
7
7
Tachycardia
7
7
Discomfort
7
7
Respiratory Distress
6
6
No Code Available
5
5
Wheezing
5
5
Laceration(s)
5
5
Ventilator Dependent
5
5
Bronchospasm
4
4
Device Embedded In Tissue or Plaque
4
4
Ulcer
3
3
Convulsion/Seizure
3
3
Vomiting
3
3
Swelling
3
3
Bronchitis
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien
II
Apr-01-2023
2
Flexicare Medical Ltd.
I
Nov-26-2020
3
MEDLINE INDUSTRIES, LP - Northfield
I
May-28-2024
4
Smiths Medical ASD Inc.
II
Oct-27-2021
5
Smiths Medical ASD, Inc.
I
Mar-12-2025
6
TELEFLEX LLC
I
Jun-29-2023
7
TELEFLEX LLC
II
Jan-23-2023
8
TELEFLEX MEDICAL INC
II
Jul-10-2020
9
Teleflex Medical Europe Ltd
II
Aug-19-2021
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